ERECTAID

ERECTAID is an FDA 510(k)-cleared medical device (K803111) manufactured by Burditt & Calkins-Siemens-Elema. 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, 1981. Regulation: 8.