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Orthosis, footwear, orthopaedic, shoe, insole - ARTG 405290

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 405290 and sponsored by Scholls Wellness Company Pty Ltd, manufactured by Scholl's Wellness Company Limited in United Kingdom. The device registration started on February 23, 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.

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TGA ARTG Official Data
Class I
ARTG 405290
Class I
Orthosis, footwear, orthopaedic, shoe, insole
ARTG ID: 405290
Good Name: Scholls Wellness Company Pty Ltd - Orthosis, footwear, orthopaedic, shoe, insole
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Intended Purpose

The range is intended for self-treatment of mild or intermittent aches and pains in the foot and lower body. 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.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
405290
Start Date
February 23, 2023
Effective Date
February 23, 2023
Manufacturer
Country
United Kingdom
Address
2 Arlington Square Downshire Way, Bracknell, Berkshire, RG12 1WA