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Physical therapy electrical stimulation system, battery-powered

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.

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TGA ARTG Official Data
Class IIa
Class IIa
Physical therapy electrical stimulation system, battery-powered
Australia TGA ARTG Registered Device
Good Name: OneX Medical Australia Pty Ltd - Physical therapy electrical stimulation system, battery-powered
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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.

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
Manufacturer
Country
United Kingdom
Address
PainAway House 9 Blenheim Road Longmead Business Park, Epsom, Surrey, KT19 9BE