Main information

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



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

Other information


  • 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:


Direct Healthcare Services Pty Ltd - Cushion, <specify>

ARTG entry for

Medical Device Included Class 1


Direct Healthcare Services Pty Ltd

Postal Address

PO Box 562,WEMBLEY, WA, 6913


ARTG Start Date


Product category

Medical Device Class 1



Approval area

Medical Devices


- 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.




Direct Healthcare Services Ltd

6-10 Withey Court

Western Industrial Estate, Caerphilly, CF83


1. Cushion, <specify>

Product Type

Single Device Product

Effective date



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

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.

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