MENS-O-MATIC 1XS AND MENS-O-MATIC 2XS

MENS-O-MATIC 1XS AND MENS-O-MATIC 2XS is an FDA 510(k)-cleared medical device (K904288) manufactured by Monad Corp.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 12, 1991. Regulation: 8.