934b28d2-2b43-466b-9d74-e507cb322eddUpdatePublished42021-02-192016-09-24In Commercial DistributionB3673440PrimaryHIBCCUE BioSleeve434033139835AXIOBIONICS1Cutaneous Electrode GarmentfalsefalsefalsefalsefalsefalsefalsetruefalsefalsefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK14134200035995Transcutaneous electrical stimulation electrode, single-useAn electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-use device.falseActiveGXYElectrode, Cutaneousfalsefalse