Australia TGA ARTG record

Stimulator, electrical, neuromuscular, gait

Australia TGA ARTG Registered Device · Otto Bock Australia Pty Ltd · Bioness Inc · Class IIa · Started August 17, 2017

Good Name: Otto Bock Australia Pty Ltd- Stimulator, electrical, neuromuscular, gait

Device classification

Risk Class: Class IIa
Product Type: Medical device system
ARTG Category: General

Registration information

Start Date: August 17, 2017
Effective Date: August 17, 2017

Sponsor

Name: Otto Bock Australia Pty Ltd

Manufacturer

Name: Bioness Inc
Country: United States of America
Address: 25103 Rye Canyon Loop, Valencia, CA, 91355

Intended purpose

A neuroprosthesis, battery operated, that applies electrical stimulation to the lower extremity nerves, e.g. peroneal or femoral, to cause the muscles in the leg to contract, thus improving functional gait in patients suffering from Upper motor neurone conditions such as Stoke, Incomplete SCI, Multiple Sclerosis etc.

About this record

Access comprehensive regulatory information for Stimulator, electrical, neuromuscular, gait in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Otto Bock Australia Pty Ltd, manufactured by Bioness Inc in United States of America. The device registration started on August 17, 2017.

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.