UROSTYM BIOFEEDBACK AND STIMULATION DEVICE AND ACCESSORIES

UROSTYM BIOFEEDBACK AND STIMULATION DEVICE AND ACCESSORIES is an FDA 510(k)-cleared medical device (K070331) manufactured by Laborie Medical Technologies. 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 May 3, 2007. Regulation: 8.