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Analgesic TENS system - ARTG 344151

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 registered under ARTG number 344151 and 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.

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Class IIa
ARTG 344151
Class IIa
Analgesic TENS system
ARTG ID: 344151
Good Name: Viveo Pty Ltd atf Viveo Trust - Analgesic TENS system
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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)

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
344151
Start Date
September 23, 2020
Effective Date
September 23, 2020
Manufacturer
Country
China
Address
202 2/F Building 27 Dafa Industrial Park Longxi Community, Longgang District, Shenzhen