OMNISTIM CONTINENCE+ PELVIC FLOOR STIMULATION SYSTEM

OMNISTIM CONTINENCE+ PELVIC FLOOR STIMULATION SYSTEM is an FDA 510(k)-cleared medical device (K093600) manufactured by Accelerated Care Plus. 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 December 3, 2009. Regulation: 8.