Device Dossier

Stimulator, electrical, analgesic, peripheral nerve, transcutaneous

Device Dossier for Stimulator, electrical, analgesic, peripheral nerve, transcutaneous (Analgesic TENS system, Class IIa, sponsor Primivo Pty Ltd atf…

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. The preset programs are prepared in the factory according to the customer's parameters. These electronic devices are both battery-powered and also able to use a 240 volt wall power adaptor.

TGA Public Summary