Device Dossier

Stimulator, electrical, analgesic, peripheral nerve, transcutaneous

Device Dossier for Stimulator, electrical, analgesic, peripheral nerve, transcutaneous (Analgesic TENS system, Class IIa, sponsor Allied Health Medical…

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 includes several predetermined stimulation modulation options, e.g. pulse frequency or pulse duration. It is 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.

TGA Public Summary