Chair

Main information

  • Trade name:
  • Chair, bath/shower
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Chair, bath/shower
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216583
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216583

Form Plus Function Pty Ltd - Chair, bath/shower

ARTG entry for

Medical Device Included Class 1

Sponsor

Form Plus Function Pty Ltd

Postal Address

PO Box 180,ELSTERNWICK, VIC, 3185

Australia

ARTG Start Date

25/10/2013

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

Form Plus Function Pty Ltd

1 Archibald Street

ELSTERNWICK, VIC, 3185

Australia

Products

1. Chair, bath/shower

Product Type

Single Device Product

Effective date

25/10/2013

GMDN

34936 Chair, bath/shower

Intended purpose

With the ability to work in numerous environments, this design is as much functional as it is a piece of

furniture.

Used for showering assistance and as a dressing chair in the bedroom, dressing room or bathroom, the

Dignity shower seat is perfect for both short term and ongoing assistance and safety.

Concealed rubber foot stoppers ensure confidence and safety in a wet or dry environment.

·The height adjustable seat can be customised to the users' requirements.

·Approved by Australian and International Standards (AS3973: 2009) for residential, clinical and

industrial use for clients up to 150 kg.

·This design can be used long term or short term for showering assistance as well as doubling as a

dressing chair in the bedroom or bathroom.

·Flat packed with an easy 3-step assembly for local and internationally delivery.

·Lightweight and at only 6kg is easily moved.

·Several can be purchased so that seats can be positioned and left in wet, dry and dressing areas.

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 http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 19.10.2017 at 01:25:57 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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