Walking

Main information

  • Trade name:
  • Walking aid, two arms, chair
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Walking aid, two arms, chair
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220763
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220763

PME Group Pty Ltd - Walking aid, two arms, chair

ARTG entry for

Medical Device Included Class 1

Sponsor

PME Group Pty Ltd

Postal Address

PO Box 1118,Young, NSW, 2594

Australia

ARTG Start Date

6/03/2014

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

Thomas Hilfen fur Korperbehinderte GmbH

Walkmujlenstrasse 1

D-27432

Bremervorde, ,

Germany

Products

1. Walking aid, two arms, chair

Product Type

Single Device Product

Effective date

6/03/2014

GMDN

31120 Walking aid, two arms, chair

Intended purpose

A mobility aid for children used as a gait trainer to assist a disabled or infirm child in walking.It consists of a

wheeled frame with a seat/sling.

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 10.11.2017 at 03:12:29 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