Pure Global

Orthosis, spinal, lumbosacral, corset, flexible

Access comprehensive regulatory information for Orthosis, spinal, lumbosacral, corset, flexible in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is 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
Class I
Orthosis, spinal, lumbosacral, corset, flexible
Australia TGA ARTG Registered Device
Good Name: RF Six Pty Ltd - Orthosis, spinal, lumbosacral, corset, flexible
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

The devices are high quality orthopaedic back supports and stabilizer products ergonomically designed to aid in recovery from injuries, provide extra support and stability to back. it is like a flexible orthopaedic corset designed to encompass the lumbosacral spine region of the trunk to support or immobilize deformities, fractures, sprains, or strains of the spine through compression of the abdomen. The devices are ergonomically designed for wearer comfort, and made from a selection of skin-friendly elastic and rigid materials. They provide compression that assist in healing of injuries and sprains. The back support product range includes: Adjustable Support in different sizes Support with lifting belt in different sizes

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
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