Australia TGA ARTG record

Stimulator, electrical, analgesic, peripheral nerve, transcutaneous

Australia TGA ARTG Registered Device · Ultimate Health & Wellbeing Group Pty Ltd · Gemore Technology Co Ltd · Class IIa · Started June 19, 2009

Good Name: Ultimate Health & Wellbeing Group Pty Ltd - Stimulator, electrical, analgesic, peripheral nerve, transcutaneous

Device classification

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

Registration information

Start Date: June 19, 2009
Effective Date: June 19, 2009

Sponsor

Name: Ultimate Health & Wellbeing Group Pty Ltd

Manufacturer

Name: Gemore Technology Co Ltd
Country: Taiwan
Address: 11F / 29-5 / Section 2 / Chung Cheng E Road, Tan Shui, Taipei Hsien

Intended purpose

An analgesic peripheral nerve stimulator consisting of an external stimulator and electrode placed on the skin not penetrating the body at any time, so the electrical stimulus is applied through the skin (transcutaneously) to the painful area. It typically includes several predetermined stimulation modulation options, e.g. pulse frequency or pulse duration. Most are portable, battery powered and worn on a belt or carried in a pocket. This device is also known as a transcutaneous electric nerve stimulator (TENS) and is used to treat pain associated with surgery, trauma, musculoskeletal problems, bursitis or dental problems. It is also used in physical therapy and during labour/delivery.

About this record

Access comprehensive regulatory information for Stimulator, electrical, analgesic, peripheral nerve, transcutaneous in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Ultimate Health & Wellbeing Group Pty Ltd, manufactured by Gemore Technology Co Ltd in Taiwan. The device registration started on June 19, 2009.

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.