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truFlex - Physical therapy electrical stimulation system, battery-powered

Access comprehensive regulatory information for truFlex - 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 Cutera Australia Pty Ltd, manufactured by Johari Digital Healthcare Ltd in India. The device registration started on July 31, 2020.

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
truFlex - Physical therapy electrical stimulation system, battery-powered
Australia TGA ARTG Registered Device
Good Name: Cutera Australia Pty Ltd - truFlex - Physical therapy electrical stimulation system, battery-powered
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Intended Purpose

Electrically-powered unit intended to apply electrical stimulation transcutaneously for muscle strengthening, toning, and firming and for the treatment of obesity. It includes an electric current pulse generator and noninvasive electrodes.

Device Classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
July 31, 2020
Effective Date
July 31, 2020
Manufacturer
Country
India
Address
G-582/584 EPIP Zone Boranada, Jodhpur, Rajasthan, 342012