Australia TGA ARTG record

Primo EMS560 - Electromechanical orthopaedic extracorporeal shock wave therapy system

Australia TGA ARTG Registered Device · Alpha Vital Pty Ltd · EMS Physio Ltd · Class IIb · Started June 26, 2024

Good Name: Alpha Vital Pty Ltd - Primo EMS560 - Electromechanical orthopaedic extracorporeal shock wave therapy system

Device classification

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

Registration information

Start Date: June 26, 2024
Effective Date: June 26, 2024

Sponsor

Name: Alpha Vital Pty Ltd

Manufacturer

Name: EMS Physio Ltd
Country: United Kingdom
Address: Grove Technology Park, Downsview Road, Wantage, Oxfordshire, OX12 9FE

Intended purpose

The Primo EMS560 is indicated for applying radial shock wave energy for pain relief and improved function in the treatment of the following chronic musculoskeletal conditions: Plantar fasciitis, Achilles tendinopathy, Patellar tendinopathy and Lateral epicondylitis.

About this record

Access comprehensive regulatory information for Primo EMS560 - Electromechanical orthopaedic extracorporeal shock wave therapy system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Alpha Vital Pty Ltd, manufactured by EMS Physio Ltd in United Kingdom. The device registration started on June 26, 2024.

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.