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Alternating-pressure bed mattress overlay system

Access comprehensive regulatory information for Alternating-pressure bed mattress overlay system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Acacia No 1 Trust T/a Forte Healthcare Solutions, manufactured by Pe & Le Enterprise Ltd in Taiwan. The device registration started on September 10, 2014.

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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TGA ARTG Official Data
Class I
Class I
Alternating-pressure bed mattress overlay system
Australia TGA ARTG Registered Device
Good Name: Acacia No 1 Trust T/a Forte Healthcare Solutions - Alternating-pressure bed mattress overlay system
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Intended Purpose

An assembly of devices consisting of an alternating-pressure bed mattress overlay and a dedicated pump, which also functions as the control unit, designed to actively alternate a bed occupant's bed-contact points, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized (especially in cases of decubitus ulcers), patients with disabilities, or patients with low body fat.

Device Classification
Risk Class
Class I
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
September 10, 2014
Effective Date
September 10, 2014
Manufacturer
Country
Taiwan
Address
16-5 266 Sec 1 Wunhua 2nd Road, Linkou Township, Taipei Country, 24448