Cushion

Main information

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

Documents

Localization

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

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222558
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222558

Direct Healthcare Services Pty Ltd - Cushion, <specify>

ARTG entry for

Medical Device Included Class 1

Sponsor

Direct Healthcare Services Pty Ltd

Postal Address

PO Box 562,WEMBLEY, WA, 6913

Australia

ARTG Start Date

16/04/2014

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

Direct Healthcare Services Ltd

6-10 Withey Court

Western Industrial Estate, Caerphilly, CF83

Products

1. Cushion, <specify>

Product Type

Single Device Product

Effective date

16/04/2014

GMDN

11093 Cushion, <specify>

Intended purpose

The Dyna ± Tek Gel Advance is the flagship cushion within the Direct Healthcare Range. Designed using

the latest medical grade silicone gel technology to create greater postural management and pressure

re-distribution, whilst providing cooling properties for the user. This product is specifically made for users

considered to be at "High / Very High Risk" of pressure ulcer development and those with minor postural

issues. The pre-contoured foam base creates an excellent foundation for pelvic stability, whilst by using a

waterproof, closed cell foam, it allows the product to be extremely lightweight and durable. Primarily at

home in a wheelchair environment, this product can also be used in a ward or homecare setting. The

Dyna-Tek Gel Advance gives comfort to the user with ultimate peace of mind towards care.

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 09:04:46 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