Device Dossier

Analgesic TENS system

Device Dossier for Analgesic TENS system (Analgesic TENS system, Class IIa, sponsor Viveo Pty Ltd atf Viveo Trust). ARTG record, intended purpose, GMDN…

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. These electronic devices are battery-powered. (AAA & 3.7V Li-ion battery)

TGA Public Summary