Pure Global

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 Le Reve HealthCare Pty Ltd (AKA Caremax), manufactured by Shenzhen Roundwhale Technology Co Ltd in China. The device registration started on September 20, 2019.

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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class IIa
Class IIa
Physical therapy electrical stimulation system, battery-powered
Australia TGA ARTG Registered Device
Good Name: Le Reve HealthCare Pty Ltd (AKA Caremax) - Physical therapy electrical stimulation system, battery-powered
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

The electrical stimulator is a combination unit with TENS and EMS function. The intended use for TENS and EMS mode is stated below: TENS mode: To be used for relief of chronic body pain, acute post traumatic pain or acute post surgical pain. It is also used in physical therapy and during labour/delivery. EMS mode: it is typically used to speed up muscle recovery and strengthen the weak muscles, to improve blood circulation, to preserve muscle mass to improve mobility.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
September 20, 2019
Effective Date
September 20, 2019
Manufacturer
Country
China
Address
202 2/F Building 27 Dafa Industrial Park Longxi Community, Longgang District, Shenzhen