
Elidah, Inc.
Free shipping on orders over $99 · 30-day returns
Elitone for Men is an FDA 510(k)-cleared medical device (K253285) manufactured by Elidah, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 22, 2026. Regulation: 8.