Device Dossier

Stimulator, electrical, analgesic, peripheral nerve, transcutaneous

Device Dossier for Stimulator, electrical, analgesic, peripheral nerve, transcutaneous (Analgesic TENS system, Class IIa, sponsor Le Reve HealthCare Pty…

Intended purpose

The XFT tens machine, is a transcutaneous electrical nerve stimulator, designed for the symptomatic relief and management of chronic pain. The device consists of an external low frequency stimulator and electrode pads. The pads can be placed on the skin and not penetrating the body at any time. It includes several predetermined stimulation modulation options, eg pulse frequency and/or duration. This unit is battery powered and can be worn on a belt or in a pocket.

TGA Public Summary