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…
- GMDN category: Analgesic TENS system
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.