Electrode Pad

The Electrode Pad is a cutaneous electrode accessory designed to transmit electrical current to patient skin for use with transcutaneous electrical stimulation devices, including TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation) systems. It is non-sterile, intended for single adult patient multiple application use, and available in various shapes and sizes for both over-the-counter and prescription applications.

The device consists of a top cover, connector (snap button or lead wire), conductive carbon film, conductive hydrogel media, and PET carrier liner. Key differences from the predicate include reduced electrode pad sizes (rectangle 50×100mm vs. 40×40mm–40×350mm range) and consequently different patient contact areas, but similar hydrogel thickness (0.75±0.15mm vs. 1.0±0.2mm), electrode impedance (426–635Ω vs. 415–688Ω), and conductive materials (PU/PE vs. PU conductive film).

ISO 10993-5:2009 (in vitro cytotoxicity), ISO 10993-10:2021 (skin sensitization), ISO 10993-23:2021 (skin irritation), ASTM F1980-16 (accelerated aging), 180° stainless steel peel strength testing, ANSI AAMI IEC 60601-2-2 (impedance testing), and AAMI/ANSI ES 60601-1 (lead wire electrical safety).

The device is substantially equivalent because it shares the same intended use, regulatory classification (Class II cutaneous electrode), indications for use, target population, materials, and electrical/biocompatibility performance characteristics with the predicate. The minor size and contact area differences do not introduce new safety or effectiveness risks, as confirmed by identical electrical safety and impedance testing results, and biocompatibility testing demonstrates equivalent safety performance.