Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Neurotek Pty Ltd - Stimulator, electrical, neuromuscular, gait
ARTG entry for
Medical Device Included Class IIa
Neurotek Pty Ltd
PO Box 3174,WAREEMBA, NSW, 2046
ARTG Start Date
Medical Device Class IIa
- 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.
25103 Rye Canyon Loop
Valencia, CA, 91355
United States Of America
1. Stimulator, electrical, neuromuscular, gait
Medical device system
35725 Stimulator, electrical, neuromuscular, gait
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.
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 http://www.tga.gov.au/about/website-copyright.htm.
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.
Visit www.tga.gov.au for contact information