Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)

The Elde Medical Electrodes are cutaneous electrodes used to transmit electrical current from transcutaneous electrical stimulation devices (such as TENS and EMS units) through a conductive hydrogel to patient skin. They come in two sizes: 5 cm × 5 cm and 5 cm × 10 cm, are non-sterile, and intended for single-patient multiple-application use in both over-the-counter and prescription settings.

The subject device uses a top cover, lead wire with female socket connection, conductive carbon film, biocompatible conductive hydrogel (1.0 mm ±0.1 mm thick), and PET carrier liner. It demonstrates impedance less than 300 ohms and meets electrical safety standards per IEC 60601-1. The predicate uses similar materials with slightly different hydrogel thickness (0.75 mm ±0.15 mm) and higher impedance (426–635 ohms), but both share identical sizes, materials, shelf life, and adhesion performance.

ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2021 (skin sensitization), ISO 10993-23:2021 (irritation), ASTM F1980-21 (accelerated aging), ASTM D4169-23 (shipping container performance), 180° stainless steel peel strength testing, impedance testing per IEC 60601-2-2, and lead wire testing per IEC 60601-1.

The subject device is substantially equivalent because it has identical indications for use, design (rectangle and square shapes), materials, sizes, patient contact areas, shelf life, sterilization status (non-sterile), and biocompatibility standards as the predicate. The lower impedance (<300 ohms vs. 426–635 ohms) does not present new or increased risks and supports efficient current transfer without altering effectiveness. All non-clinical testing confirms the device is as safe and effective as the predicate.