Foam-filled chair cushion

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

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Available from:
AA-Med Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
323914

Public Summary

Summary for ARTG Entry:

323914

Fusidium Pty Ltd - Foam-filled chair cushion

ARTG entry for

Medical Device Included Class 1

Sponsor

AA-Med Pty Ltd

Postal Address

Level 8 / 1 Chandos Street,St Leonards, NSW, 2065

Australia

ARTG Start Date

23/09/2019

Product category

Medical Device Class 1

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

Accora Ltd

Charter House Barrington Road

Orwell, Cambridge, SG8 5QP

United Kingdom

Products

1. Foam-filled chair cushion

Product Type

Single Device Product

Effective date

23/09/2019

GMDN

44361 Foam-filled chair cushion

Intended purpose

An accessory that may be used with alternating pressure chair cushion system to reduce the risk of users

developing pressure damage.

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 04:00:08 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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