Multi-terrain

Main information

  • Trade name:
  • Multi-terrain sports wheelchair, attendant/occupant-driven
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Multi-terrain sports wheelchair, attendant/occupant-driven
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220916
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220916

KSM Mobility Beach Chairs - Multi-terrain sports wheelchair, attendant/occupant-driven

ARTG entry for

Medical Device Included Class 1

Sponsor

KSM Mobility Beach Chairs

Postal Address

82 Grant Street,PORT MACQUARIE, NSW, 2444

Australia

ARTG Start Date

7/03/2014

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

KSM Mobility Beach Chairs

82 Grant Street

PORT MACQUARIE, NSW, 2444

Australia

Products

1. Multi-terrain sports wheelchair, attendant/occupant-driven

Product Type

Single Device Product

Effective date

7/03/2014

GMDN

46137 Multi-terrain sports wheelchair, attendant/occupant-driven

Intended purpose

Mobile chair device to allow persons with disabilities and others to access and float in the water at

beaches, rivers, pools with assistance of a support person.

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 02:46:16 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

26-10-2018

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