Wheelchair

Main information

  • Trade name:
  • Wheelchair,
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Wheelchair,
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222040
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222040

Drive Medical Pty Ltd - Wheelchair, <specify>

ARTG entry for

Medical Device Included Class 1

Sponsor

Drive Medical Pty Ltd

Postal Address

The Metro 1st Floor Apartment 15 63 Porcas Street,SOUTH MELBOURNE, VIC, 3205

Australia

ARTG Start Date

6/04/2014

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

Drive DeVilbiss Healthcare Ltd

Healthfield Lane

Birkenshaw, West Yorkshire, BD11 2HW

Products

1. Wheelchair, <specify>

Product Type

Single Device Product

Effective date

6/04/2014

GMDN

14449 Wheelchair, <specify>

Intended purpose

A wheeled personal mobility device incorporating a seating support system for a disabled user, e.g. a

handicapped person or a person not having the full capacity to walk by him or herself, e.g. a hospital

patient or an elderly person. The device is propelled by an attendant and/or the occupant, either manually

or by some kind of powered mechanism. This device can be configured in a number of ways to suit the

specific requirements of the user. It may be collapsible or non-collapsible.

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 09.11.2017 at 10:56:41 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