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Analgesic TENS system

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 Tempo Australia Pty Ltd, manufactured by Shenzhen Roundwhale Technology Co Ltd in China. The device registration started on October 12, 2021.

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
Class IIa
Analgesic TENS system
Australia TGA ARTG Registered Device
Good Name: Tempo Australia Pty Ltd - Analgesic TENS system
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Intended Purpose

The device is intended to treat various muscular and joint conditions by a combination of TENS, EMS and Massage functions. The battery-powered device is used to reduce the perception of pain by electrically stimulating peripheral nerves across the skin, it consists of an external current generator and electrodes that are placed on the skin to provide the transcutaneous analgesic electrical stimulus to the painful area. The Massage stimulation function provides relaxing muscle vibration to loosen tight muscles.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
October 12, 2021
Effective Date
October 12, 2021
Manufacturer
Country
China
Address
202 2/F Building 27 Dafa Industrial Park Longxi Community, Longgang District, Shenzhen