9c5e7447-3542-4210-b283-3fcf942836b5UpdatePublished22023-12-182023-01-09In Commercial DistributionE10001Unit of UseHIBCCB618E2PrimaryHIBCCControlSeal Electrode Domes (Standard Size)1078505297COAPT LLC9Non-invasive, cutaneous electrode for use with recording and monitoring equipment of Electromyography (EMG). falsefalsefalsefalsefalsefalsefalsetruetruefalsefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK22360500061020Analytical non-scalp cutaneous electrodeAn electrical conductor designed to be attached to the skin surface of a patient outside of the hair line (i.e., non-scalp) to conduct electrical signals to/from a parent device for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), nerve conduction study (NCS), bioelectrical impedance]; it is not primarily intended for diagnostic electrocardiography (ECG) or electroencephalography (EEG). It typically consists of a small rectangular tab or cup/disk with a conductive surface, which may include a lead wire. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.falseActiveGXYElectrode, Cutaneousfalsefalse