Device Dossier
Stimulator, electrical, analgesic, peripheral nerve, transcutaneous
Device Dossier for Stimulator, electrical, analgesic, peripheral nerve, transcutaneous (Analgesic TENS system, Class IIa, sponsor Ultimate Health &…
- GMDN category: Analgesic TENS system
- Sponsor: Ultimate Health & Wellbeing Group
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 typically includes several predetermined stimulation modulation options, e.g. pulse frequency or pulse duration. Most are 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.