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Primo EMS560 - Electromechanical orthopaedic extracorporeal shock wave therapy system - ARTG 453705

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 registered under ARTG number 453705 and 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.

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Class IIb
ARTG 453705
Class IIb
Primo EMS560 - Electromechanical orthopaedic extracorporeal shock wave therapy system
ARTG ID: 453705
Good Name: Alpha Vital Pty Ltd - Primo EMS560 - Electromechanical orthopaedic extracorporeal shock wave therapy system
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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.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
453705
Start Date
June 26, 2024
Effective Date
June 26, 2024
Manufacturer
Country
United Kingdom
Address
Grove Technology Park, Downsview Road, Wantage, Oxfordshire, OX12 9FE