Device Dossier

Tens Circulation - Analgesic TENS system

Device Dossier for Tens Circulation - Analgesic TENS system (Analgesic TENS system, Class IIa, sponsor AU Remedials). ARTG record, intended purpose, GMDN…

Intended purpose

A device intended to be used to treat pain associated with musculoskeletal problems. 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. Portable, battery powered and worn on a belt or carried in a pocket.

TGA Public Summary