Elitone for Men

Elitone for Men is a non-implanted electrical muscle stimulator designed to aid early continence recovery in men immediately following prostate surgery. It delivers therapeutic stimulation to the pelvic floor muscles via a disposable electrode applied to the skin in the perineal region, with a small control unit allowing patients to adjust stimulation intensity during a multi-week treatment regimen.

The subject device has identical technological characteristics to the predicate Elitone device, including shared components. The only difference is the electrode component, which has an anatomically-shaped profile corresponding to male anatomy rather than female anatomy. The materials, construction, and performance parameters of the electrodes are otherwise identical.

The FDA guidance document 'Guidance Document for Powered Muscle Stimulator 510(k)s' was used to determine applicable bench tests. The 'Output Specifications' table from that guidance served as the template for characterizing controller performance. Performance of the electrode component, including maximum current density, was characterized and found substantially equivalent to the predicate female electrode.