Stimulator, electrical, neuromuscular, gait

Australia - English - Department of Health (Therapeutic Goods Administration)

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Otto Bock Australia Pty Ltd
Class IIa
Authorization status:
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Public Summary

Summary for ARTG Entry:


Neurotek Pty Ltd - Stimulator, electrical, neuromuscular, gait

ARTG entry for

Medical Device Included Class IIa


Neurotek Pty Ltd

Postal Address

PO Box 3174,WAREEMBA, NSW, 2046


ARTG Start Date


Product category

Medical Device Class IIa



Approval area

Medical Devices


- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.




Bioness Inc

25103 Rye Canyon Loop

Valencia, CA, 91355

United States Of America


1. Stimulator, electrical, neuromuscular, gait

Product Type

Medical device system

Effective date



35725 Stimulator, electrical, neuromuscular, gait

Intended purpose

A neuroprosthesis, battery operated, that applies electrical stimulation to the lower extremity nerves, e.g.

peroneal or femoral, to cause the muscles in the leg to contract, thus improving functional gait in patients

suffering from Upper motor neurone conditions such as Stoke, Incomplete SCI, Multiple Sclerosis etc.

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at

Public Summary

Page 1 of

Produced at 03.11.2017 at 06:37:33 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

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