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Air-filled chair cushion

Access comprehensive regulatory information for Air-filled chair cushion in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by The Care Kiosk Pty Ltd, manufactured by Systam Systems Assistance Medical in France. The device registration started on January 10, 2018.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.

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Class I
Class I
Air-filled chair cushion
Australia TGA ARTG Registered Device
Good Name: The Care Kiosk Pty Ltd - Air-filled chair cushion
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Intended Purpose

POLYAIRยฎ cushions are used to treat and prevent decubitus ulcers on the buttocks. By delivering variable volumes of air via an air valve skin breakdown is mitigated and comfort is sustained. The patient buttocks make contact with the cushion surface which moulds itself to the individuals'anatomy. This results in extremely effective reduction in transcutaneous pressure values (as measured by 3D pressure imaging devices) on the buttock areas with little or no counter-pressure.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
January 10, 2018
Effective Date
January 10, 2018
Manufacturer
Country
France
Address
ZAE Route de Casseneuil, 47300 Villenueve Sur Lot