Australia TGA ARTG record

Bioness H200W - Physical therapy electrical stimulation system, battery-powered

Australia TGA ARTG Registered Device · Otto Bock Australia Pty Ltd · Bioness Inc · Class IIa · Started April 09, 2018

Good Name: Otto Bock Australia Pty Ltd - Bioness H200W - Physical therapy electrical stimulation system, battery-powered

Device classification

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

Registration information

Start Date: April 09, 2018
Effective Date: April 09, 2018

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 non invasive battery powered device indicated for the treatment of paralysis from hemiplegic stroke, traumatic brain injury or C5-C6 spinal cord injury to prevent muscle atrophy, for muscle re-education, to relax muscle spasms, to improve blood circulation, and/or to maintain or increase range of motion. The system contains a custom-fit orthosis, electrodes, and controller that delivers functional electrical stimulation (FES) to activate muscle groups in the limb to produce functional movement.

About this record

Access comprehensive regulatory information for Bioness H200W - Physical therapy electrical stimulation system, battery-powered 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 April 09, 2018.

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.