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Electromechanical orthopaedic extracorporeal shock wave therapy system

Access comprehensive regulatory information for Electromechanical orthopaedic extracorporeal shock wave therapy system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Whiteley Medical Supplies Pty Ltd, manufactured by Shenzhen Dongdixin Technology Co Ltd in China. The device registration started on June 27, 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 IIa
Class IIa
Electromechanical orthopaedic extracorporeal shock wave therapy system
Australia TGA ARTG Registered Device
Good Name: Whiteley Medical Supplies Pty Ltd - Electromechanical orthopaedic extracorporeal shock wave therapy system
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DJ Fang

DJ Fang

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Intended Purpose

The Shockwave Therapy Device is a treatment system for the electromagnetic generation and application of radial shock waves in orthopaedics and physiotherapy. It is used to relieve pain and provide treatment of myofascial pain syndrome, plantar fasciitis and patellar tendinopathy. Shockwave Therapy Device is a non-invasive method that uses pressure waves to treat various conditions in the body. Acoustic waves deliver a mechanical force to the bodyโ€™s tissues that carries high energy to painful spots and musculoskeletal tissues. The device main unit adjusts the intensity and frequency of the pressure pulse output by controlling the coil in the handpiece connected to the main unit and driving the projectile to hit the applicator. The operator can control the output of the handpiece through the trigger button on the handpiece. The shock waves created by the impact are transmitted through the skin in contact with the applicator. Medical effects of shockwaves include new blood vessel formation, reversal of chronic inflammation, stimulation of collagen production, dissolution of calcified fibroblasts and release of trigger points.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
June 27, 2024
Effective Date
June 27, 2024
Manufacturer
Country
China
Address
Floor 1-2 No 3 Building Fanshen Xusheng Industrial Estate Xilixiaobaimang, Nanshan District, Shenzhen, 518108