Orthosis, footwear, orthopaedic, shoe, insole - ARTG 320284
Access comprehensive regulatory information for Orthosis, footwear, orthopaedic, shoe, insole in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 320284 and sponsored by Scholls Wellness Company Pty Ltd, manufactured by Reckitt Benckiser Healthcare (UK) Limited in United Kingdom. The device registration started on July 17, 2019.
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 range is intended for self-treatment of mild or intermittent aches and pains in the foot and lower body of non-diagnosed pain sufferers. The Scholl InBalance insole range is not suitable for chronic, severely acute pains or pains likely attributable to a trauma or a severe gait abnormality. The physical, primary mode of action of the range is designed to cushion, shock absorb and support the relevant areas of the foot to help reduce and re-distribute forces experienced by the foot and lower body, which in turn can reduce foot and lower body pain attributable to the mechanical stresses produced from the lower kinetic chain.