Cushion

Main information

  • Trade name:
  • Cushion, sitting, wheelchair
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Cushion, sitting, wheelchair
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219985
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219985

Motum Pty Ltd - Cushion, sitting, wheelchair

ARTG entry for

Medical Device Included Class 1

Sponsor

Motum Pty Ltd

Postal Address

3 / 224 Cambridge Street,WEMBLEY, WA, 6014

Australia

ARTG Start Date

7/02/2014

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

Anatomic SITT

Stohagsgatan 26

Norrkoping, , SE-602 29

Sweden

Products

1. Cushion, sitting, wheelchair

Product Type

Single Device Product

Effective date

7/02/2014

GMDN

11100 Cushion, sitting, wheelchair

Intended purpose

A seating system that can be used by people with physical disability. The Sharky Pro is a flexible and

adjustable seating insert, and has been designed specifically for users with fluctuating muscle tone,

particularly active extensor tone, and can also accommodate a wide variety of musculo-skeletal difficulties.

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 05:46:57 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