Australia TGA ARTG recordPhysical therapy electrical stimulation system, battery-powered
Australia TGA ARTG Registered Device · Le Reve HealthCare Pty Ltd (AKA Caremax) · Shenzhen Roundwhale Technology Co Ltd · Class IIa · Started September 20, 2019
Good Name: Le Reve HealthCare Pty Ltd (AKA Caremax) - Physical therapy electrical stimulation system, battery-powered
- Risk Class
- Class IIa
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- September 20, 2019
- Effective Date
- September 20, 2019
- Country
- China
- Address
- 202 2/F Building 27 Dafa Industrial Park Longxi Community, Longgang District, Shenzhen
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.
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.