Details
Device typeBalance therapy translingual electrical stimulation system: An assembly of electronic devices intended to electrically stimulate the tongue during physical therapy to help rehabilitate body balance, and sometimes gait. The device may: 1) provide biofeedback for training of balance by sensing body movements and producing signals translated into electrical stimuli applied to the tongue enabling a patient to correlate electrotactile stimulation with head/body position; or 2) combine sensorimotor activity with tongue stimulation to modulate brain activity (neuromodulation), via the trigeminal nerve, and treat chronic balance/gait deficits. It consists primarily of a wearable pulse generator/controller and connected electrode array applied to the tongue.
FDA categoryElectrical Tongue Stimulator To Treat Motor Deficits
Device ID00810188050779
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information