CDSCO risk classification
Rehabilitation medical device classification
Every rehabilitation device in CDSCO's classification register, with its risk class under the Medical Devices Rules, 2017 and its intended use. 67 are Class A non-sterile, non-measuring devices, which are exempt from licensing but must be registered.
- Devices
- 115
- Class A
- 86
- Class B
- 21
- Class C
- 8
- Class D
- 0
Rehabilitation devices and their class
115 devices
Abdominal Support
Rehabilitation
Class AIt holds abdominal muscles together to relieve pain. Increase circulation at your surgical site to promote healing and decrease swelling. Make physical activity more comfortable.
Acupressure calf band
Rehabilitation
Class AIntended to wear around the calf to apply pressure to an acupressure point to relieve low back pain, including sciatica and piriformis syndrome. A Non-powered belt like device.
Adhesive pad for Transcutaneous electrical stimulation electrode
Rehabilitation
Class ANon-sterile, non-measuringReusable gel pads that allow TENS electrodes (not included) to adhere gently to the skin.
Anti-tremor gyroscopic orthotic glove
Rehabilitation
Class ANon-sterile, non-measuringA battery-powered device intended to be worn on the hand/forearm of a patient with hand tremors [e.g., due to Parkinson’s disease, Essential tremor (ET)] to reduce tremors, promote hand stabilization, and facilitate activities of daily living using the hand.
Arm sling
Rehabilitation
Class ANon-sterile, non-measuringAn arm sling is a device intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
Arthritis TENS system
Rehabilitation
Class BIntended to be used as adjunctive therapy in reducing the level of pain and stiffness associated with rheumatoid arthritis or osteoarthritis by electrically stimulating peripheral nerves across the skin (transcutaneous).
Back Support/Brace
Rehabilitation
Class ANon-sterile, non-measuringA back brace prevents unnecessary movements that further damage the back. This helps align your spine and strengthen your back muscles. Patients back can heal and back pain will decrease.
Back/leg/chest dynamometer, electronic
Rehabilitation
Class BPowered device intended to assess neuromuscular function by measuring the force or power exerted by the back, chest, and/or leg muscles during flexion.
Back/leg/chest dynamometer, mechanical
Rehabilitation
Class ANon powered device intended to assess neuromuscular function by measuring the force or power exerted by the back, chest, and/or leg muscles during flexion.
Balance-training tongue electrical stimulation system
Rehabilitation
Class BIntended to provide biofeedback for training of balance by sensing body movements and subsequently producing signals which are translated into electrical stimuli applied to the tongue, enabling a patient to correlate electrotactile stimulation with their head and body position during exercise sessions.
Bed/chair electric massager
Rehabilitation
Class BIntended to provide therapeutic massage to the occupant of a bed or chair for the treatment of body aches and pains.
Bicycle ergometer
Rehabilitation
Class AIntended to be used to provide a quantitative measurement of the rate at which work (energy) is performed by a muscle or group of muscles under controlled conditions.
Bladder-emptying vibratory stimulator
Rehabilitation
Class BIntended to initiate urination and facilitate complete bladder emptying through application of small mechanical vibrations to the lower abdomen to promote urethral sphincter relaxation.
Blue/red/infrared phototherapy lamp
Rehabilitation
Class AIntended to emit blue light, red light, and infrared radiation (heating effect) for phototherapy treatment of mild skin disorders (e.g., mild acne), superficial skin wounds, and musculoskeletal symptoms (e.g., pain, spasm, stiffness).
Bobath table
Rehabilitation
Class ANon-sterile, non-measuringIntended for postural exercises, rolling, turning and balance training of patients with loss of sensation or poor balance and other neurological conditions such as stroke, head injury and orthopedic indications.
Cable-controlled external hand prosthesis
Rehabilitation
Class ANon-sterile, non-measuringIntended as an artificial hand for physically disabled persons, whose movement can be controlled by a cable.
Cervical traction kit (with/without weights)
Rehabilitation
Class ANon-sterile, non-measuringIntended for traction of cervical region in conditions such as neck or back pain, post surgery rehabilitation, reducing neck pressure, etc.
Cervical traction spreader bar/ Spreader bar
Rehabilitation
Class ANon-sterile, non-measuringIntended to serve as a component of a traction kit to relieve pressure by stretching the musculature and connective tissue components of the cervical spine.
Circulating-fluid thermal therapy system
Rehabilitation
Class BIntended to be used to pump heated and/or cooled fluid (e.g., water) through externally applied packs for localized hot and/or cold therapy to help treat a variety of adverse conditions resulting from musculoskeletal injury (e.g., pain, swelling, inflammation).
Cold compression therapy cervical spine collar
Rehabilitation
Class AIntended to facilitate, through cooling and compression, the treatment of a variety of conditions resulting from injury/surgery to the neck region (e.g., inflammation, stiffness, whiplash).
Cold compression therapy cervical spine collar/ Ice collar
Rehabilitation
Class ANon-sterile, non-measuringIntended to facilitate, through cooling and compression, the treatment of a variety of conditions resulting from injury/surgery to the neck region (e.g., inflammation, stiffness, whiplash).
Cold-air therapy unit
Rehabilitation
Class BIntended to reduce localized pain/inflammation, and/or to reduce thermal skin damage by applying cold stream of air during dermatological laser treatments.
Cold/cool therapy gel
Rehabilitation
Class ANon-sterile, non-measuringintended for localized topical skin application to provide a cooling effect for underlying muscles/joints to reduce pain and swelling.
Congenital hip dislocation abduction splint
Rehabilitation
Class ANon-sterile, non-measuringA congenital hip dislocation abduction splint is a device intended for medical purposes to stabilize the hips of a young child with dislocated hips in an abducted position (away from the midline).
Controlled ankle motion (CAM) walker
Rehabilitation
Class ANon-sterile, non-measuringIntended for preventing/limiting foot/ankle movement in cases of serious sprain, surgery or removal of cast.
Core-body mechanical weight exerciser
Rehabilitation
Class AIntended to enable a patient with a lumbar spine injury to perform controlled extension, contraction, and/or twisting movements of the lumbar/thoracic spine back region and the abdomen, for testing and rehabilitation.
Crutches
Rehabilitation
Class ANon-sterile, non-measuringCrutches helps to transfer load from the legs to the upper body. This is useful for people who cannot use their legs to fully support the weight of their body, due to temporary or permanent disabilities.
Deep-tissue electromagnetic stimulation system
Rehabilitation
Class BIntended to apply an electromagnetic (EM) field to body tissues to: 1) treat musculoskeletal disorders (e.g., osteoarthritis, osteoporosis) 2) treat body pain (musculoskeletal, postsurgical) and/or 3) help facilitate soft and hard tissue wound/injury healing, with no production of a therapeutic deep heat.
Denis Brown splint
Rehabilitation
Class ANon-sterile, non-measuringA Denis Brown splint is a device intended for medical purposes to immobilize the foot. It is used on young children with tibial torsion (excessive rotation of the lower leg) or club foot.
Electromechanical orthopaedic extracorporeal shock wave therapy system
Rehabilitation
Class CIntended to provide electromechanical orthopaedic extracorporeal shock wave therapy (OEST) to treat musculoskeletal disorders.
Electronic goniometer/kinesiol ogy sensor
Rehabilitation
Class BIntended to evaluate a patient’s range of motion/movement of individual joints/limbs/spine it is used in a clinical setting typically before/after a medical/surgical intervention, or to assess degree of physical fitness.
Electronic Mobility Aid
Rehabilitation
Class ANon-sterile, non-measuringAn electronic device having no measuring function, intended for use with an assistive mobility cane (white cane) to assist visually impaired persons with safe mobility and navigation by detecting obstacles above knee level using ultrasound technology in both indoor and outdoor environments.
Exothermic heat therapy pack
Rehabilitation
Class AIntended to be applied to the body surface, sometimes with pressure, to provide heat therapy to reduce muscle spasms and cramps and/or for joint and muscle stiffness and pain.
External arm prosthesis socket
Rehabilitation
Class ANon-sterile, non-measuringA device intended to fit over the terminal end of a residual upper limb and serves as an interface between the limb and an artificial replacement arm segment (external prosthesis).
External arm prosthesis, pediatric, non-powered
Rehabilitation
Class ANon-sterile, non-measuringExternal non-powered artificial hand or arm prosthesis for physically disabled pediatric patients.
External asembled lower limb prosthesis
Rehabilitation
Class ANon-sterile, non-measuringAn external assembled lower limb prosthesis is a device that is intended for medical purposes and is a preassembled external artificial limb for the lower extremity. Examples of external assembled lower limb prostheses are the following: Knee/shank/ankle/foot assembly and thigh/knee/shank/ankle/foot assembly.
External limb orthotic component
Rehabilitation
Class ANon-sterile, non-measuringAn external limb orthotic component is a device intended for medical purposes for use in conjunction with an orthosis (brace) to increase the function of the orthosis for a patients particular needs. Examples of external limb orthotic components include the following: A brace-setting twister and an external brace stirrup.
External limb prosthesis socket liner
Rehabilitation
Class ANon-sterile, non-measuringThe prosthetic liner acts as an interface that goes between a person's skin and his or her prosthetic. In short, it's a barrier – one that is applied to the skin before the prosthesis to protect the wearer's skin while enhancing comfort and maintaining a more consistent fit.
External limb prosthetic component
Rehabilitation
Class ANon-sterile, non-measuringAn external limb prosthetic component is a device intended for medical purposes that, when put together with other appropriate components, constitutes a total prosthesis. Examples of external limb prosthetic components include the following: Ankle, foot, hip, knee, and socket components mechanical or powered hand, hook, wrist unit, elbow joint, and shoulder joint components and cable and prosthesis suction valves.
External lower-limb prosthesis socket
Rehabilitation
Class ANon-sterile, non-measuringA component of an external lower limb prosthesis intended to fit over a residual limb after amputation at any hip, knee, or ankle-foot level, and intended to function as the limb-prosthesis interface and to provide support, stabilization and suspension.
External silicone breast prosthesis
Rehabilitation
Class ANon-sterile, non-measuringIntended to restore normal contour and improve function for patients who have experienced partial or total loss of their breast to traumatic injury, disease or due to surgical removal of the nose (rhinectomy).
Finger/hand exerciser
Rehabilitation
Class ANon-sterile, non-measuringIntended primarily to strengthen the muscles of the fingers and hands through repetitive finger/hand motion against resistance from elasticity or density (post fracture/stress/weak forearm and grip strength).
Finger/thumb prosthesis
Rehabilitation
Class ANon-sterile, non-measuringAn artificial substitute for a missing finger or thumb.
Flex bar
Rehabilitation
Class ANon-sterile, non-measuringIntended to increase tendon strength and reduce elbow pain for those who suffer from tennis and golfer's elbow.
Foot sensorimotor therapy mechanical neurostimulator
Rehabilitation
Class CIntended to provide non-invasive peripheral neurostimulation to the feet for improving somatosensory integration, typically for reducing motor impairments and balance disturbances in patients with neurological or neurodegenerative disorders (e.g., Parkinson's disease).
Foot traction kit
Rehabilitation
Class ANon-sterile, non-measuringIt is used in relieving pain due to muscle spasm, maintaining the limb in a position of comfort and to restore and maintain the alignment of bone due to fracture or dislocation.
Gait analysis system
Rehabilitation
Class AIntended to be used to study walking or running patterns.
Gait rehabilitation electronic walker
Rehabilitation
Class ANon-sterile, non-measuringIt is intended to assist a patient with a walking disability (neurogenic, muscular, or orthopaedic in origin) to regain lost motor function, which may include rising from sitting to standing and/or ambulation over ground (not on a treadmill). It is intended to be used in a clinical setting under healthcare professional supervision. This does not have a measuring function (e.g., vital monitoring, distance measurement, etc.).
Gait Trainer, non-powered
Rehabilitation
Class ANon-sterile, non-measuringA non-powered device intended to assist and train a person with physical disabilities to relearn/improve walking.
Gel knee ring
Rehabilitation
Class ANon-sterile, non-measuringIntended to be worn around the knee for pain relief and immobilization.
Grip-enhancing exoskeleton
Rehabilitation
Class ANon-sterile, non-measuringIntended to improve grip strength and hand function for people (from children to elderly people) with impaired hand function. The condition may be (but is not limited to) due to orthopaedic or neurological problems, from birth or acquired. This does not have a measuring function.
Hand dynamometer/pinch meter, electronic
Rehabilitation
Class AAn electronic device intended to assess neuromuscular function by measuring the force or power exerted by the muscles of the hand/forearm to squeeze/pinch an object. It may be used during muscle activity monitoring during rehabilitation and aid in rehabilitation therapy planning. It does not provide direct diagnosis of any medical condition or disease or pathological state.
Hand dynamometer/pinch meter, mechanical
Rehabilitation
Class AMechanical device intended to assess neuromuscular function by measuring the force or power exerted by the muscles of the hand/forearm to squeeze/pinch an object.
Hand exerciser table
Rehabilitation
Class ANon-sterile, non-measuringThis modality exerciser is intended for rehabilitation of the hands, fingers, and wrist disorders injuries and fractures.
Heal cushion/Spur pad/cup
Rehabilitation
Class ANon-sterile, non-measuringIntended to be worn on the heel to relieve heel pain, plantar fascitis, foot pain, pain during walking, calcaneal spur, sprain and strain of the foot, ankle, feet and knee pain, etc.
Hydraulic/pneumatic external knee prosthesis
Rehabilitation
Class ANon-sterile, non-measuringThis device is intended for transfemoral amputees to restore some function of an anatomical knee joint.
Hydrotherapy treadmill
Rehabilitation
Class APowered device intended for use in partially immersed in water, e.g., in a hydrotherapy tank, to provide additional resistance to the treadmill walking exercise without increasing the impact and/or stress on the patients joints.
Image display monitor mount
Rehabilitation
Class ANon-sterile, non-measuringA dedicated mount onto which a visual display unit (VDU), e.g., a patient monitor (not included), can be placed and secured so that it is safely mounted in a position suitable for viewing. It is manufactured for hospital use.
Interferential electrical stimulation system
Rehabilitation
Class CIntended to stimulate peripheral nerves through the transcutaneous application of two currents of slightly different frequencies that cross-over/interfere, producing a beating frequency at the treatment point.
Inversion table, physiotherapy
Rehabilitation
Class ANon-sterile, non-measuringIntended to support the body of a patient and provide traction for the back muscles and spine by allowing the patient to manually invert their entire body in a supine position (feet up and head down), thereby assist in alleviating back pain.
Jaw exerciser, non-powered
Rehabilitation
Class ANon-sterile, non-measuringIntended to be used to exercise jaw muscles for temporomandibular disorders, increased saliva production, helping to improve efficient food chewing and swallowing.
Kinesiology tape
Rehabilitation
Class ANon-sterile, non-measuringIntended for use to support and relieve pain in muscles, joints, and/or ligaments. It may aid in reducing swelling, increasing mobility and enhancing recovery rate.
Lower limb exerciser, non- measuring
Rehabilitation
Class ANon-sterile, non-measuringIntended to provide above and below knee amputees the ability to improve muscle and strengthen residual limbs. This does not have a measuring function.
Lower limb sliding exerciser, non-powered
Rehabilitation
Class ANon-sterile, non-measuringA non-powered device intended to encourage active movement of a patient’s lower limb(s) by assisting flexion/extension at the knee for rehabilitation. This is a reusable device.
Manual dexterity test
Rehabilitation
Class ANon-sterile, non-measuringDexterity devices intended to evaluate motor coordination, depth perception and eye-hand coordination in a subjective manner. This does not have AI--integrated or measuring function.
Manual goniometer
Rehabilitation
Class ANon powered device intended to be used in a clinical setting to measure the range of motion of the limb of a patient by measuring the angle of movement achieved at the joint.
Mechanical-resistance external ankle-foot prosthesis
Rehabilitation
Class ANon-sterile, non-measuringExternal prosthetic components for the purpose of replacement for a foot/ankle. The foot/ankle is intended to be used for a lower limb external prosthetic system.
Mechanical-resistance external knee prosthesis
Rehabilitation
Class ANon-sterile, non-measuringAn externally applied component intended for use in replacement of the knee joint (or other) in persons with limb amputation or difference.
Mechatronic external ankle- foot prosthesis
Rehabilitation
Class ANon-sterile, non-measuringA battery-powered device intended for use as part of an external prosthetic system that replaces the foot and ankle function of a missing lower limb.
Medium-wave diathermy treatment system
Rehabilitation
Class BIntended to produce a therapeutic deep heat within specific volumes of the body through the transcutaneous transmission of electromagnetic (EM) energy in the radio-frequency (RF) bands of 0.5 MHz to 1 MHz
Microwave diathermy treatment system
Rehabilitation
Class BIntended to produce a therapeutic heat 1 to 2 cm below the skin within specific volumes of the body through the transcutaneous transmission of high frequency electromagnetic (EM) energy, typically 2,450 megahertz (MHz) [microwave], to promote tissue healing and pain relief.
Moist-cold pack
Rehabilitation
Class ANon-sterile, non-measuringA non-sterile device intended to be temporarily applied to a particular area of the body surface to provide moist cold for purposes such as reduction in inflammation, control bleeding, relief in discomfort due to fever, etc.
Multi-chamber venous compression system garment
Rehabilitation
Class ANon-sterile, non-measuringA garment intended for use with a compression system (not included) in preventing deep vein thrombosis (DVT) as well as the treatment of edema secondary to venous insufficiency.
Musculoskeletal infrared phototherapy unit,
Rehabilitation
Class BIntended to provide a source of infrared (IR) heat for localized treatment of musculoskeletal pain/injury (e.g., muscle pain, sports injury, rheumatism) and to improve blood circulation in the treated areas to facilitate healing.
Musculoskeletal intense therapeutic ultrasound system
Rehabilitation
Class CIntended to produce and deliver intense therapeutic ultrasound (ITU) waves through the skin to create ablative lesions in subcutaneous soft tissues (e.g., muscles, tendons).
Musculoskeletal/ physical therapy laser
Rehabilitation
Class CIntended to provide noninvasive laser therapy [e.g., infrared phototherapy, low-level laser therapy (LLLT)] for localized treatment of musculoskeletal conditions (e.g., muscle pain, sports injury, disorders of the joints and soft/connective tissues), improving blood circulation in the treated areas to facilitate healing, or for non- needle acupuncture.
Myoelectric forequarter-amputation prosthesis
Rehabilitation
Class AThe complete control system is to be used exclusively for external prosthetic fitting of the upper limbs.
Myoelectric Hand Prosthesis
Rehabilitation
Class ANon-sterile, non-measuringA powered artificial substitute for a missing hand intended to be attached to a natural arm or used as part of an upper-limb external prosthetic system, to replace the appearance and some of the function of the hand. It has surface electrodes in contact with skin that transmit voluntary residual limb/trunk movement to the device motor for function. This is a single patient-use device.
Oral exerciser, Physiotherapy
Rehabilitation
Class ANon-sterile, non-measuringA non-powered device that is intended to exercise tongue muscles as part of oral myology physiotherapy.
Parallel bar exerciser,
Rehabilitation
Class ANon-sterile, non-measuringIntended to assist users in maintaining good walking posture, particularly a person with a disability, a paraplegic, or a patient who has suffered a stroke and is learning to walk.
Pedal exerciser
Rehabilitation
Class ANon-sterile, non-measuringA non-powered device intended for exercise therapy for upper and/or lower body. This is a non-measuring device.
Pelvic floor exercise biofeedback device
Rehabilitation
Class ANon-sterile, non-measuringIt is intended to facilitate regular pelvic floor exercises for strengthening of the pelvic floor muscles and rehabilitation and training of weak pelvic floor muscle. This may aid in treatment of urinary incontinence, improving function in individuals with existing pelvic floor dysfunction, improving pelvic floor function in the post-partum period and/or improving mild to moderate prolapse symptoms. This does not estimate/quantify muscle contraction forces and does not have any other measuring function.
Pelvic traction kit (with/without weights)
Rehabilitation
Class ANon-sterile, non-measuringA set of non-powered equipment intended to apply uniform and controlled traction to the lumbar, sacral, and thoracic areas of the vertebral column. It does not have a measuring function (or measuring graduations).
Physical therapy massager
Rehabilitation
Class BElectrically powered device intended to provide therapeutic massage to a larger area than hand-held massaging devices.
Physical therapy paraffin wax bath
Rehabilitation
Class BIntended to be filled with liquid paraffin wax for physical therapy.
Physical therapy steam bath
Rehabilitation
Class BIntended to apply hot steam as a physical therapy to a patient.
Physical therapy table, line powered
Rehabilitation
Class ANon-sterile, non-measuringIntended to facilitate functional training of patients/subjects with loss of lower extremity, upper extremity or core functionality, caused by conditions of orthopedic, musculoskeletal, neurological, or other origin by providing muscular load in combination with visual feedback.
Pneumatic external knee joint
Rehabilitation
Class ANon-sterile, non-measuringIntended to replace knee joint in persons with lower limb amputation and connecting to above knee prosthesis
Power Knee
Rehabilitation
Class BThe Power Knee is a motor-powered microprocessor knee. It provides active assistance while walking on level-ground, climbing and descending ramps or stairs and when standing up. Power Knee enables amputees to maintain and regain mobility and participate in the daily activities.
Powered lower extremity exoskeleton
Rehabilitation
Class BA powered lower extremity exoskeleton is a prescription device that is composed of an external, powered, motorized orthosis that is placed over a person's paralyzed or weakened limbs for medical purposes.
Prosthesis External Arm
Rehabilitation
Class AExternal prosthesis for upper limb distal to shoulder joint. The device is intended to be used by patients with upper limb loss or deficiency. Prosthesis may include limb components, socket, frame, covering and accessories to enable functional use of the device.
Prosthesis, external, arm, component, hand, external powered, myopotential
Rehabilitation
Class AA controller for prosthetic terminal devices that enables grip and mode switching using passive RFID tags.
Prosthetic and orthotic accessory
Rehabilitation
Class AA prosthetic and orthotic accessory is a device intended for medical purposes to support, protect, or aid in the use of a cast, orthosis (brace), or prosthesis. Examples of prosthetic and orthotic accessories include the following: A pelvic support band and belt, a cast shoe, a cast bandage, a limb cover, a prosthesis alignment device, a postsurgical pylon, a transverse rotator, and a temporary training splint.
Prosthetic external arm, non- powered
Rehabilitation
Class ANon-sterile, non-measuringA non-powered, mechanical device intended to be used as an external prosthesis for upper limb distal to shoulder joint by patients with upper limb loss or deficiency.
Prosthetic external foot (Winged Foot)
Rehabilitation
Class ANon-sterile, non-measuringA non-powered, mechanical device intended for persons with a lower-limb amputation to restore lost mobility.
Prosthetic external foot, pediatric
Rehabilitation
Class ANon-sterile, non-measuringA non-powered, mechanical device intended for children with a lower-limb amputation to restore lost mobility.
Pulmonary exerciser
Rehabilitation
Class ANon-sterile, non-measuringThe device is a handheld device that is intended to improve expiratory/exhalation and inspiratory/inhalation muscle strength for the enhancement of breathing, coughing, swallow, voice and fitness.
Pulsed signal therapy system
Rehabilitation
Class CIntended to regenerate damaged cartilage, particularly by stimulating the production of collagen types that are present in healthy cartilage.
Seasonal Affective Disorder Phototherapy Unit
Rehabilitation
Class BA powered device intended to mimic normal daylight as an aid in treating patients with seasonal affective disorder (SAD) syndrome and improve the patient's mental condition, sleep or sleep inertia, and to reduce mood disorders. This may be a wearable device. This does not emit ionizing radiation.
Shaped ankle wedge prosthesis, adult
Rehabilitation
Class ANon-sterile, non-measuringIntended to be used as external artificial joint that is designed to replace the ankle joint in adults.
Shaped ankle wedge prosthesis, pediatric
Rehabilitation
Class ANon-sterile, non-measuringIntended to be used as external artificial joint that is designed to replace the ankle joint in children
Short-wave diathermy treatment system
Rehabilitation
Class CIntended to provide a therapeutic deep heat within specific volumes of the body through the transcutaneous transmission of electromagnetic (EM) energy in the radio-frequency (RF) bands of 13 MHz to 27.12 MHz
Shoulder wheel
Rehabilitation
Class ANon-sterile, non-measuringA non-powered device intended for use to perform resistance exercises to improve range of motion and relieve pain in patients (intended for hospital use).
Silicone Prosthetic Ear
Rehabilitation
Class ANon-sterile, non-measuringA silicone prosthetic ear which adheres to the skin using safe, biocompatible glue is a reconstructive option for patients born with microtia and other birth differences such as Treacher Collins or Goldenhar syndrome as well as those who have suffered traumatic injury or undergone cancer resection surgery.
Silicone Prosthetic Nose
Rehabilitation
Class ANon-sterile, non-measuringSilicone prosthetic nose is used to restore normal contour and improve function for patients who have experienced partial or total loss of their nose to traumatic injury, disease or due to surgical removal of the nose (rhinectomy).
Soft rehabilitation glove
Rehabilitation
Class ANon-sterile, non-measuringIntended for rehabilitation training of patients with finger joint dysfunction.
Solid-ankle-cushion-heel (SACH) foot
Rehabilitation
Class ANon-sterile, non-measuringIntended for persons with a lower-limb amputation to restore lost mobility
Stocking, medical support
Rehabilitation
Class ALimb support shaped as a stocking unit that is worn on the upper or lower extremity to support, correct, prevent deformity, or to align body structures for functional improvement.
Telemetric diagnostic spirometer
Rehabilitation
Class BIt is a Battery powered portable device Intended to measure several or all respiratory-gas volume and flow parameters needed to evaluate basic pulmonary function [e.g., vital capacity (VC), peak expiratory flow (PEF), forced expiratory volume (FEV), and forced expiratory flow (FEF)], and to transmit the pulmonary function data via a communication device to a healthcare professional(s) at a remote server.
Therapeutic nuclear magnetic resonance system
Rehabilitation
Class CIntended to influence cellular metabolism using nuclear magnetic resonance (NMR) for the treatment of degenerate and pathological changes to the movement/support profiles of a patients body, in particular diseased skeletal joints, bones, and surrounding muscle tissue (e.g., cervical and lumbar spine, shoulders, elbows, hands, hips, knees, feet).
TruncalOrthosis
Rehabilitation
Class AA truncalorthosis is a device intended for medical purposes to support or to immobilize fractures, strains, or sprains of the neck or trunk of the body. Examples of truncalorthoses are the following: Abdominal, cervical, cervical-thoracic, lumbar, lumbo-sacral, rib fracture, sacroiliac, and thoracic orthoses and clavicle splints.
Upper extremity prosthesis including a simultaneously powered elbow and/or shoulder with greater than two simultaneous powered degrees of freedom and controlled by non-implanted electrical components.
Rehabilitation
Class BA upper extremity prosthesis including a simultaneously powered elbow and/or shoulder with greater than two simultaneous powered degrees of freedom and controlled by non-implanted electrical components, is a prescription device intended for medical purposes, and is intended to replace a partially or fully amputated or congenitally absent upper extremity. It uses electronic inputs (other than simple, manually controlled electrical components such as switches) to provide greater than two independent and simultaneously powered degrees of freedom and includes a simultaneously powered elbow and/or shoulder. Prosthetic arm components that are intended to be used as a system with other arm components must include all degrees of freedom of the total upper extremity prosthesis system.
Vaginal exerciser/Pelvic floor muscle exerciser, female
Rehabilitation
Class ANon-sterile, non-measuringIntended to provide Kegel exercises to strengthen and tone the pelvic floor muscle, which in turn improves conditions such as female incontinence, sexual dysfunction, prolapse, etc.
Vagus Nerve Stimulation Device
Rehabilitation
Class BA powered, non-invasive device intended to stimulate the auricular branch (peripheral branch) of the vagus nerve by low energy electrical pulses, as an aid in improving sleep quality, reducing stress, and maintaining a balanced nervous system. It is used for individuals experiencing insomnia, anxiety-related sleep disturbances, or general restlessness. This is a reusable device.
Weight activated knee joint external prosthesis
Rehabilitation
Class ANon-sterile, non-measuringIntended as an artificial external knee with a braking mechanism that prevents the knee from bending as long as the user has weight on the prosthesis.
Data from CDSCO's online system for medical devices, retrieved 2026-10-31.
Sources
- Risk Classification Approved Device Details, CDSCO online system for medical devices. Retrieved 31 October 2026.
- Merged existing medical devices risk classification, CDSCO public notice, 1 January 2025.
See the full source list and how the data is compiled on the main classification page. This is a reference aid, not legal or regulatory advice.
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