Electrotherapy Electrodes

Electrotherapy Electrodes are disposable, self-adhesive conductive interfaces placed between a patient's skin and electrical stimulation devices (TENS, EMS, IF, or PGF stimulators) to transmit electrical current. They consist of five layers: tan fabric backing, double-sided adhesive tape, carbon conductive film, self-adhesive conductive hydrogel, and plastic release film, with leadwire/snap button connections. The electrodes are available in multiple sizes and shapes for single-patient, single-application use.

The subject device is a five-layer disposable electrode with carbon film conduction, compared to the predicate's three-layer reusable design using aluminum foil or carbon film. Both employ self-adhesive conductive hydrogels, leadwire/snap button connections, and .080" (2mm) female socket connectors. The subject device meets ≤160 ohms AC impedance versus the predicate's <200 ohms. Both are non-sterile, suitable for OTC or prescription use, and comply with ISO 10993 biocompatibility requirements.

Electrical safety per IEC 60601-1; IEC 60601-2-2 Edition 6.0 (2017-03) for high-frequency surgical equipment; ASTM D4169-23 for shipping container performance; ISO 10993-5 (cytotoxicity), ISO 10993-10 (skin sensitization), and ISO 10993-23 (irritation) for biocompatibility; plus shelf-life testing and custom testing for impedance, dimensions, and connector performance.

The subject device shares the same intended use (disposable conductive interface for electrical stimulation) and nearly identical technological characteristics as the predicate—same adhesive type, electrical connections, impedance performance, and biocompatibility compliance. The key difference is that the subject device is disposable rather than reusable; however, this change in use designation does not raise new safety or effectiveness concerns because both are single-patient use, non-sterile, and employ the same materials and functional design. Verification and biocompatibility testing confirmed the device meets performance specifications and material safety standards equivalent to the predicate.