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:
  • 222560
  • 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

United Kingdom


1. Cushion, <specify>

Product Type

Single Device Product

Effective date



11093 Cushion, <specify>

Intended purpose

The Dyna ± Flex Cushion incorporates the most exclusive combination of visco elastic & CMHR foam

technology, providing not only outstanding pressure re-distribution, but great patient comfort. The

temperature sensitive memory foam softens at patient interface, thus giving even weight distribution, whilst

the CMHR underside prevents the foam from bottoming out. Suitable for patients considered to be at "High

Risk" of pressure ulcer development, the Dyna ± Flex gives nursing security without the patient

challenging the issue of comfort. Complete with a well designed cover and non-slip base, this product is

ideal for use in conjunction with any modern wheelchair.

Specific Conditions

No Specific Conditions included on Record

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written approval from the Commonwealth.Further details can be found at

Public Summary

Page 1 of

Produced at 09.11.2017 at 09:04:16 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.

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