Pure Global

Orthosis, leg, ankle/foot, unit - ARTG 370903

Access comprehensive regulatory information for Orthosis, leg, ankle/foot, unit in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 370903 and sponsored by RF Six Pty Ltd, manufactured by Ningbo Raffini Import & Export Co Ltd in China. The device registration started on July 12, 2021.

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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class I
ARTG 370903
Class I
Orthosis, leg, ankle/foot, unit
ARTG ID: 370903
Good Name: RF Six Pty Ltd - Orthosis, leg, ankle/foot, unit
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

The devices are high quality orthopedic ankle braces, support, wraps and stabilizer products designed to help relieve pain in ankles, aid in recovery from injuries, and improve overall comfort. The Wagner range of ankle may also be used to help prevent sprains, strains and other forms of joint instabilities. The devices are ergonomically designed for excellent wearer comfort, and made from a selection of skin-friendly elastic and rigid materials They provide compression which may reduce swelling, and improve the elasticity of muscles, tendons and ligaments, while assisting in the healing of injuries and sprains. Wagner Body Science Ankle range includes the following products: Elastic Ankle support in various sizes Adjustable braces in different sizes Adjustable Wrap Support Adjustable thermal support

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
370903
Start Date
July 12, 2021
Effective Date
July 12, 2021
Sponsor
Manufacturer
Country
China
Address
No 155 Tonghui Road Hong Tang Jiang Bei District, Ningbo, 315033