Device Dossier

Electrode, transcutaneous, electrical nerve stimulation

Device Dossier for Electrode, transcutaneous, electrical nerve stimulation (Electrode, transcutaneous, electrical nerve stimulation, Class IIb, sponsor…

Intended purpose

The device is a single use electrode. The device is intended to provide local muscle stimulation and local tissue heating for the purpose of elevating tissue temperature and increase in local blood circulation resulting in strengthening of facial muscles and reduction of facial wrinkles and rhytids. The single use cheek electrodes are intended to relieve symptoms associated with muscle spasm, treat temporomandibular joint (TMJ) dysfunction and pain, support muscle re-education, increase blood flow, and maintain or increase mandibular range of motion.

TGA Public Summary