Device Dossier
Analgesic TENS system
Device Dossier for Analgesic TENS system (Analgesic TENS system, Class IIa, sponsor Neurotone). ARTG record, intended purpose, GMDN category — compiled…
- GMDN category: Analgesic TENS system
Intended purpose
This TENS & EMS combination device is a battery operated pulse generator that sends electrical impulses to the body in order to stimulate nerves or muscle groups. The device consists of an external stimulator and electrodes, which are fitted to the external skin of the person using the device. The device is intended to be used for pain relief and neural stimulation. One such method will be transcutaneous vagus nerve stimulation applied at the external ear. The device is pre-loaded with programs and has dual output channels with intensity controlled on the device by the user according to their need.