Wheelchair, occupant-driven, bimanual-chain-operated, collapsible - ARTG 429671
Access comprehensive regulatory information for Wheelchair, occupant-driven, bimanual-chain-operated, collapsible in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 429671 and sponsored by Oceania Medical Technologies Pty Ltd, manufactured by Foshan Dahao Medical Technology Co Ltd in China. The device registration started on December 04, 2023.
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.
The manufacturer's intended purpose of the manual wheelchair encompasses its structural design, operational guidelines, maintenance recommendations, and ideal usage scenarios. The manual wheelchair is meticulously crafted with a frame, front and rear wheels, armrests, footrests, anti-tip wheels, handles, handgrips, seat cushion, backrest, and brakes. Its design prioritises both safety and convenience. Noteworthy features include an easily foldable high-strength metal frame and a lightweight overall structure, ensuring ease of use and portability. Operationally, the wheelchair's setup involves placing it on a flat surface, attaching the quick-release rear wheels, and securing the seat cushion in place by pressing down on designated points. Folding the wheelchair is a straightforward process involving raising the footrest and lifting the seat cushion. Additionally, the wheelchair includes iron brake components to ensure stability when parked and a rear tilting wheel for navigating steps. Maintenance guidelines emphasize the wheelchair's nature as a reusable, non-sterile product without toxic materials. The device's safety and effectiveness are contingent upon structural integrity, user behaviour, environmental conditions, regular maintenance, and adherence to usage recommendations. Replacement procedures for worn parts such as front wheels and frame cleaning are provided, with a caution against using lubricants and an emphasis on promptly addressing any structural issues. Lastly, the ideal placement of the wheelchair is highlighted to prevent malfunctions. Direct sunlight, heat sources, high humidity, extreme temperatures, corrosive environments, vibrations, and unstable surfaces are all locations to avoid for optimal functionality. Overall, the manufacturer's intended purpose of the manual wheelchair is to provide a safe, convenient, and portable mobility aid. Its design and operational features prioritise user safety, ease of use, and manoeuvrability in various environments while emphasising the importance of regular maintenance and appropriate placement for long-term functionality and user satisfaction.