Summary for ARTG Entry:
Direct Healthcare Services Pty Ltd - Cushion, <specify>
ARTG entry for
Medical Device Included Class 1
Direct Healthcare Services Pty Ltd
PO Box 562,WEMBLEY, WA, 6913
ARTG Start Date
Medical Device Class 1
- 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>
Single Device Product
11093 Cushion, <specify>
The Dyna ± Tek Gel Cushion has been designed using the latest polyurethane gel. By incorporating the
most advanced raw materials during the manufacturing process, enhanced postural management and
greater pressure re-distribution is achieved. The cooling gel surface assists any modern pressure ulcer
management process by providing a minor reduction of the skin surface temperature. This product is
specifically made for users considered to be at "High / Very High Risk" of pressure ulcer development.
Equally at home in a ward, homecare or wheelchair environment, Dyna-Tek Gel gives advanced comfort
and greater care to the user.
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.
Page 1 of
Produced at 09.11.2017 at 09:05:03 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