Australia TGA ARTG record

Lumbar spine orthosis

Australia TGA ARTG Registered Device · RF Six Pty Ltd · Ningbo Raffini Import & Export Co Ltd · Class I · Started April 18, 2023

Good Name: RF Six Pty Ltd - Lumbar spine orthosis

Device classification

Risk Class: Class I
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: April 18, 2023
Effective Date: April 18, 2023

Sponsor

Name: RF Six Pty Ltd

Manufacturer

Name: Ningbo Raffini Import & Export Co Ltd
Country: China
Address: No 155 Tonghui Road Hong Tang Jiang Bei District, Ningbo, 315033

Intended purpose

An externally applied orthopaedic appliance or apparatus designed to encompass the lumbar spine region of the trunk to support or immobilise deformities, fractures, sprains, or strains of the spine. This is a reusable device. 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 the 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. The support is designed with stabilising bars to provide extra support and stability to the back. They provide compression that assist in healing of injuries and sprains. The back support product range includes adjustable support in different sizes, an additional lumbar support pad that can be removed by the wearer

About this record

Access comprehensive regulatory information for Lumbar spine orthosis 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 April 18, 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.