Australia TGA ARTG record

Analgesic TENS system

Australia TGA ARTG Registered Device · Viveo Pty Ltd atf Viveo Trust · Shenzhen Roundwhale Technology Co Ltd · Class IIa · Started September 23, 2020

Good Name: Viveo Pty Ltd atf Viveo Trust - Analgesic TENS system

Device classification

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

Registration information

Start Date: September 23, 2020
Effective Date: September 23, 2020

Sponsor

Name: Viveo Pty Ltd atf Viveo Trust

Manufacturer

Name: Shenzhen Roundwhale Technology Co Ltd
Country: China
Address: 202 2/F Building 27 Dafa Industrial Park Longxi Community, Longgang District, Shenzhen

Intended purpose

The unit is a non-invasive device designed for the purpose of assisting in the treatment and management of chronic and acute pain. These machines are designed to gently stimulate the muscles/nerves under the skin through sending electrical pulsations through cables to surface electrodes placed on the skin to stimulate the nerve fibres. The unit integrates TENS and/or EMS functions with preset programs and/or programmable functions. These electronic devices are battery-powered. (AAA & 3.7V Li-ion battery)

About this record

Access comprehensive regulatory information for Analgesic TENS system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Viveo Pty Ltd atf Viveo Trust, manufactured by Shenzhen Roundwhale Technology Co Ltd in China. The device registration started on September 23, 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.