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Wheelchair accessory/component, bracket - ARTG 459629

Access comprehensive regulatory information for Wheelchair accessory/component, bracket in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 459629 and sponsored by Pride Mobility Products Australia Pty Ltd, manufactured by Stealth Products in United States of America. The device registration started on August 15, 2024.

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
ARTG 459629
Class I
Wheelchair accessory/component, bracket
ARTG ID: 459629
Good Name: Pride Mobility Products Australia Pty Ltd - Wheelchair accessory/component, bracket
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Intended Purpose

This is a wheelchair accessory. A device when added to an existing wheelchair, will provide segmented postural management for the end user. Support is provided in two anatomical segments: a fixed support at the pelvis and an articulating thoracic segment. Anatomically-appropriate adjustable pivot points and articulation paths create a system that significantly reduces shear force. Caregivers are able to lock the thoracic segment in a chosen position. By allowing the thoracic segment to move while actively supporting the pelvis, the system helps to maintain overall seating postures. Locking struts of various forces result in the system being available to end users who exhibit a wide range of tonal patterns. The products discussed in this document are intended to be used as one component in the end user's overall seating and mobility equipment interventions and care regimens.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
459629
Start Date
August 15, 2024
Effective Date
August 15, 2024
Manufacturer
Country
United States of America
Address
104 John Kelly Drive, Burnet, TX, 78611