f1065b21-e9e2-4ced-97df-ceed44994b24NewPublished12026-01-012025-12-24In Commercial Distribution06970341670528PrimaryGS1NAOM-COMP-BFLY-2PK529401134GMDASZ manufacturing Co., Ltd.1falsefalsefalsefalsefalsefalsetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety InformationtruetrueK16013800065318Transcutaneous electrical stimulation electrode, reusableAn 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 reusable device.falseActiveGXYElectrode, Cutaneousfalsefalse