Wheelchair

Main information

  • Trade name:
  • Wheelchair accessory, power assisted conversion kit,
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Wheelchair accessory, power assisted conversion kit,
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222623
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222623

Drive Medical Pty Ltd - Wheelchair accessory, power assisted conversion kit,

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

17/04/2014

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

Ainsleys Industrial Estate

Elland, West Yorkshire, HX59JP

Products

1. Wheelchair accessory, power assisted conversion kit,

Product Type

Single Device Product

Effective date

17/04/2014

GMDN

36233 Wheelchair accessory, power assisted conversion kit,

Intended purpose

A device that can only fulfil its purpose when used together with and to enhance the function of a

wheelchair. It will provide the occupant/assistant with a powered driving assistance.

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 08:49:18 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