Australia TGA ARTG record

Physical therapy electrical stimulation system, battery-powered

Australia TGA ARTG Registered Device · OneX Medical Australia Pty Ltd · Tenscare Limited · Class IIa · Started July 25, 2023

Good Name: OneX Medical Australia Pty Ltd - Physical therapy electrical stimulation system, battery-powered

Device classification

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

Registration information

Start Date: July 25, 2023
Effective Date: July 25, 2023

Sponsor

Name: OneX Medical Australia Pty Ltd

Manufacturer

Name: Tenscare Limited
Country: United Kingdom
Address: PainAway House 9 Blenheim Road Longmead Business Park, Epsom, Surrey, KT19 9BE

Intended purpose

TENS AND EMS GMDN Code: 46573 These are medical devices designed to be used in the home healthcare environment to improve muscle tone and bulk, as well as provide symptomatic relief and management of acute or chronic localised pain and muscle pain. It is suitable for use by all who can control the devices and understand the instructions.

About this record

Access comprehensive regulatory information for 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 OneX Medical Australia Pty Ltd, manufactured by Tenscare Limited in United Kingdom. The device registration started on July 25, 2023.

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.