Fortress 3-in-1-Combo - Analgesic TENS system

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

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Available from:
Axis Medical & Rehabilitation
Class:
Class IIa
Authorization status:
Included
Authorization number:
322492

Public Summary

Summary for ARTG Entry:

322492

Axis Medical & Rehabilitation - Fortress 3-in-1-Combo - Analgesic TENS system

ARTG entry for

Medical Device Included Class IIa

Sponsor

Axis Medical & Rehabilitation

Postal Address

PO Box 1947,BOWRAL, NSW, 2576

Australia

ARTG Start Date

30/08/2019

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

Shenzhen Roundwhale Technology Co Ltd

202 2/F Building 27 Dafa Industrial Park Longxi

Community

Longgang District, Shenzhen,

China

Products

1. Fortress 3-in-1-Combo - Analgesic TENS system

Product Type

Medical device system

Effective date

30/08/2019

GMDN

35372 Analgesic TENS system

Intended purpose

Intended to treat various muscular and joint conditions by a combination of TEN, EMS and Message

functions. The device is intended to relieve pain and discomfort when used correctly.

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 05:38:36 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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