Arm rehabilitation system

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

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Available from:
Neurotek Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
324286

Public Summary

Summary for ARTG Entry:

324286

Neurotek Pty Ltd - Arm rehabilitation system

ARTG entry for

Medical Device Included Class IIa

Sponsor

Neurotek Pty Ltd

Postal Address

PO Box 3174,WAREEMBA, NSW, 2046

Australia

ARTG Start Date

1/10/2019

Product category

Medical Device Class IIa

Status

Active

Approval area

Medical Devices

Conditions

- 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.

Manufacturers

Name

Address

ARTICARES PTE LTD

10 Anson Road 05-17 International Plaza

, Singapore, 079903

Singapore

Products

1. Arm rehabilitation system

Product Type

Single Device Product

Effective date

1/10/2019

GMDN

47517 Arm rehabilitation system

Intended purpose

An arm rehabilitation robot used by patients suffering sensorimotor control deficits in the upper arm and

requiring assessment and training of the upper limb. The field of application includes but not limited to

neurological rehabilitation, post traumatic rehabilitation, or orthopaedic and post-surgery rehabilitation.

Specific Conditions

© 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.

Public Summary

Page 1 of

Produced at 02.11.2019 at 03:13:16 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

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