Australia TGA ARTG record

Orthopaedic extracorporeal shock wave therapy system

Australia TGA ARTG Registered Device · Mamo Osteopathy Nominees Pty Ltd Trustee for MM Osteo Trust · Inceler Medikal Saglik Hizmetleri Sanayi Ve Ticaret Ltd Sirketi · Class IIa · Started October 17, 2018

Good Name: Mamo Osteopathy Nominees Pty Ltd Trustee for MM Osteo Trust - Orthopaedic extracorporeal shock wave therapy system

Device classification

Risk Class: Class IIa
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: October 17, 2018
Effective Date: October 17, 2018

Sponsor

Name: Mamo Osteopathy Nominees Pty Ltd Trustee for MM Osteo Trust

Manufacturer

Name: Inceler Medikal Saglik Hizmetleri Sanayi Ve Ticaret Ltd Sirketi
Country: Turkey
Address: Ivedik Organize Sanayi Bolgesi Has Emek, Sanayi Sitesi 1465 Sokak (Eski 22 Cad) No: 4 Ostim, Yenimahalle Ankara

Intended purpose

Orthopaedic extracorporeal shock wave therapy system[47032] An assembly of devices used to send pneumatically-generated extracorporeal shock wave therapy (ESWT) via a dedicated hand-held surface applicator into an area of pain within the body. Impulse frequencies can be selected allowing the treatment duration to be as short as possible. It is used for treating musculoskeletal disorders such as tendinopathies and soft tissue pain near bones, plantar fasciitis (heel pain), epicondylopathy (tennis elbow), rotator cuff tendinopathy with or without calcification, patella tendinopathy, shin splints, Achilles tendinopathy, as well as muscle related pain syndromes.

About this record

Access comprehensive regulatory information for 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 Mamo Osteopathy Nominees Pty Ltd Trustee for MM Osteo Trust, manufactured by Inceler Medikal Saglik Hizmetleri Sanayi Ve Ticaret Ltd Sirketi in Turkey. The device registration started on October 17, 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.