S.No

Name of the Medical Device 

Intended use

Classification

1

Ankle continuous passive motion exerciser

Electrical devices intended to continuously move the ankle joint (e.g.,flexion, inversion/eversion) without patient assistance during continuous passive motion (CPM) exercise therapy usually following surgery or trauma to the joint.

B

2

Cervical spine immobilization head ring

Intended to be fixed to the skull of a patient at brow level using pointed,steel, threaded bolts (typically four)that are adjusted to penetrate the outer bone of the skull.

D

3

Chest-oscillation airway secretion clearing system

Intended to rapidly inflate and deflate against the chest wall of the patient for promoting airway clearance by creating high frequency chest wall oscillation (HFCWO), resulting in the mobilization of bronchial secretions.

B

4

Finger orthosis

Intended to encompass the whole or part of the finger to support, align,prevent, or correct deformities/injuries or to improve function of the finger.

A

5

Foot orthosis

Intended to encompass the whole or part of the foot, or designed as a plantar insert, and intended to provide rigid or semi-rigid correction of the foot for persons with orthopaedic deformities/injuries of the feet

A

6

Hand orthosis

Intended to encompass the whole or part of the hand to support, align,prevent, or correct deformities/injuries or to improve function of the hand.

A

7

Hand/wrist continuous passive motion exerciser

A mains electricity (AC-powered)deviceIntended to continuously move the metacarpal/interphalangeal joints(e.g., flexion and extension) withoutpatient assistance during continuous passive motion (CPM) exercise therapy usually following surgery or trauma to the joints.

B

8

Hip/knee continuous passive motion exerciser

A mains electricity (AC-powered)device Intended to provide continuous passive motion (CPM) exercise therapy for the hip and/or knee,typically following joint surgery/traumato promote healing; some types mayalso operate with patient assistanceunder controlled active motion (CAM).

B

9

Intermittent traction system

It is an AC powered electronic device.Intended to apply and relieve pre-settraction forces from a motor through harnesses typically attached to the cervical or lumbar vertebrae.

B

10

Knee immobilizer

Intended to temporarily render the knee immovable, either preoperatively or following injury or arthroscopy.

A

11

Neuro-controlled ambulation exoskeleton

Intended to assist a patient with a walking disability (neurogenic,muscular, or osseous in origin) regain lost motor function by transmission of the patient’s residual nerve function,via cutaneous electrodes, to the devicemotor assembly.

C

12

Physical therapy massager

Electrically powered device intended to provide therapeutic massage to a larger area than hand-held massaging devices.

B

13

Shoulder continuous passive motion exerciser

It is a mains electricity (AC-powered)device Intended to continuously move the shoulder joint (e.g., flexion,rotation, adduction/abduction) withoutpatient assistance during continuouspassive motion (CPM) exercise therapy usually following surgery or trauma to the joint.

B

14

Traction table, line- powered

Intended to support a patient and to provide traction for the back muscles and spine (e.g., lumbar, cervical) by a motorized mechanical manipulation of the spine.

B

15

Cranial orthosis

Intended to be worn on the head of an infant with an abnormal head shape(e.g., due to plagiocephaly,brachycephaly, scaphocephaly), or after craniosynostosis repair surgery,to apply pressure to the cranium and improve cranial symmetry/shape during growth over a period of months.

B

16

Ankle/foot orthosis

Intended to encompass the ankle joint,or the ankle and foot, to support, align,prevent, or correct orthopaedicdeformities/injuries or to improvefunction of the ankle and/or foot; it mayalso be intended to offload andredistribute foot pressures that affectpedal circulation to improve blood flowand help heal diabetic foot ulcers or post surgical wounds.

Class A Non-Notified

17

Balance board

Intended to train patients with difficulties in balance (e.g., a paraplegic or stroke victim) walks for balance training.

Class A Non-Notified

18

Bed traction frame

Intended to treat patients with fractures and other orthopaedic disorders (e.g.,of the lower or cervical spine, hip).

Class A Non-Notified

19

Body arch traction table

Intended to support the body of a patient and provide traction for the back muscles and spine by flexing the patient into a reverse supine body/arch.

Class A Non-Notified

20

Canalith repositioning procedure chair, manual

Intended to treat balance disorders[e.g., benign paroxysmal positional vertigo (BPPV), canalithiasis] caused by displaced canaliths (otoconia) in the inner ear of the patient

Class A Non-Notified

21

Cervical spine collar

Intended to support or immobilize thecervical spine to treat deformities,fractures, sprains, or strains (often to treat whiplash resulting from an automobile accident).

Class A Non-Notified

22

Cervicothoracic spine orthosis

Intended to support or immobilize deformities, fractures, sprains, or strains of the cervicothoracic spine.

Class A Non-Notified

23

Cervicothoracolumbosacral spine orthosis

Intended to encompass the cervicothoracolumbosacral spineregion of the neck and trunk.

Class A Non-Notified

24

Collar and cuff arm sling material

Fabric and form composite materialintended to immobilize forearm, elbow,humerus or shoulder injuries.

Class A Non-Notified

25

Elbow orthosis

Intended to encompass the elbow joint to support, align, prevent, or correct deformities/injuries or to improve function of the elbow.

Class A Non-Notified

26

Flotation therapy bed, adult

Intended to minimize pressure points on a patient’s body by providing contact with as much of the body surface as possible, typically through a mattress that contains a large volume of constantly moving media, e.g.,water, air, or mud that lifts the patient to simulate a floating effect.

Class A Non-Notified

27

Flotation therapy bed, neonatal

Intended to minimize pressure points on neonatal patient’s body by providing contact with as much of the body surface as possible, typically through a mattress that contains a large volume of constantly moving media, e.g., water, air, or mud that lifts the patient to simulate a floating effect.

Class A Non-Notified

28

Hand/finger splint

Intended to immobilize an injured hand to protect injuries to, e.g., the digits,metacarpals, and wrist during thehealing process.

Class A Non-Notified

29

Horizontal non-powered traction system

Non powered device intended to be attached to a table for the application of constant horizontal traction forces to the cervical or lumbar vertebrae by means of attached harnesses whilst the patient typically lies in a supine position on the table during treatment.

Class A Non-Notified

30

Incentive spirometer

Intended to be used in respiratory therapy to encourage and motivate deep-breathing manoeuvres, typicallyfor the postsurgical treatment andprevention of atelectasis (lungcollapse) and to help facilitate airwayopening and clearing.

Class A Non-Notified

31

Kinetic bed

Intend to enable continuous change of the patient’s lying position, e.g., it can tilt the entire bed mattress support system (this includes the mattress, the framework that supports the mattress,and the bedding) lengthways,sideways or to a near vertical tilt.

Class A Non-Notified

32

Orthopaedic bed

Intended to provide support for skeletal traction to stabilize fracture sites.

Class A Non-Notified

33

Paediatric dorsiflexion slant board

Intended to be used in the treatment of various medical conditions (e.g.,congenital, neurological, post-traumatic) in paediatrics, where tendontightness and muscle contracture affect the ability to dorsiflex the foot,possibly leading to an abnormal gait

Class A Non-Notified

34

Parapodium walking frame

Intended to encompass and provide support for the body of a patient who is unable to stand unassisted to help them move (walk) by changing their centre of gravity (COG).

Class A Non-Notified

35

Shoulder immobilizer

Intended to temporarily immobilize or limit abduction of the shoulder joint to support healing of an injury or a surgical wound.

Class A Non-Notified

36

Swivel-walker

Intended to encompass and provide support for the body of a patient who is unable to stand unassisted, to help them move (walk) by rocking sideways(shifting their weight from side-to-side with a shoulder movement) which makes the footplate of the device swivel so that it “walks” forward.

Class A Non-Notified

37

Toe separator

Intended to space the toes of the foot to relieve pain, pressure/friction between toes, and/or to facilitate realignment of the toes to a natural position.

Class A Non-Notified

38

Wrist immobilizer

Intended to temporarily render the wrist immovable as therapy for non-displaced fractures, strains, sprains,and muscle injuries of the wrist.

Class A Non-Notified