Wheelchair

Main information

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

Documents

Localization

  • Available in:
  • Wheelchair accessory, restraint, occupant
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222814
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222814

PME Group Pty Ltd - Wheelchair accessory, restraint, occupant

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

26/04/2014

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

Rehabilitation Manufacturing Services Ltd

Thompson House Unit 10 Styles Close

Sittingbourne, Kent, ME10 3BF

Products

1. Wheelchair accessory, restraint, occupant

Product Type

Single Device Product

Effective date

26/04/2014

GMDN

13356 Wheelchair accessory, restraint, occupant

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 with a securing device to hold him or her in position and prevent

them from falling out of the wheelchair. It can also hold a part of the body, e.g. a limb, in a constrained

position.

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

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Public Summary

Page 1 of

Produced at 09.11.2017 at 07:47:04 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