NEOCONTROL PELVIC FLOOR THERAPY SYSTEM

NEOCONTROL PELVIC FLOOR THERAPY SYSTEM is an FDA 510(k)-cleared medical device (K001903) manufactured by Neotonus, 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 August 28, 2000. Regulation: 8.