SE-100 VACUUM ERECTION DEVICE

SE-100 VACUUM ERECTION DEVICE is an FDA 510(k)-cleared medical device (K012662) manufactured by Vts, 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 November 8, 2001. Regulation: 8.