Details
Device typeBalance therapy translingual electrical stimulation system electrode array: An arrangement of multiple electrical conductors, designed as a component of a balance therapy translingual electrical stimulation system, intended to be placed on the tongue surface to apply electrical impulses during physical therapy for balance/gait rehabilitation. It is battery-powered by a wearable pulse generator to which it is connected, whereby the combination of sensorimotor activity and tongue electrical stimulation is intended to modulate brain activity (neuromodulation), via the trigeminal nerve, to treat chronic balance/gait deficits (e.g., due to traumatic brain injury, multiple sclerosis, cerebral palsy, stroke). This is a reusable device.
FDA categoryElectrical Tongue Stimulator To Treat Motor Deficits
Device ID00810188050755
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information