Australia TGA ARTG record

Analgesic TENS system

Australia TGA ARTG Registered Device · Tempo Australia Pty Ltd · Shenzhen Roundwhale Technology Co Ltd · Class IIa · Started October 12, 2021

Good Name: Tempo Australia Pty Ltd - Analgesic TENS system

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

Sponsor

Name: Tempo Australia Pty Ltd

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 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.

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 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.