Device Dossier

Wireless TENS Device - Analgesic TENS system

Device Dossier for Wireless TENS Device - Analgesic TENS system (Analgesic TENS system, Class IIa, sponsor Luteal Lab). ARTG record, intended purpose,…

Intended purpose

A wireless transcutaneous electrical nerve stimulation (TENS) device with an integrated localised heating function. It is intended for: a) Temporary relief of pain associated with primary dysmenorrhoea (period pain, menstrual cramps), including associated lower abdominal and lower back pain. b) Temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arms, legs and feet, arising from strain from exercise or from normal household and work activities. c) Application of localised heat for the temporary relief of minor aches and pains. The device provides symptomatic relief only and is not intended to treat or cure any underlying condition.

TGA Public Summary