GLOBUS GENESY 1100 STIMULATOR

GLOBUS GENESY 1100 STIMULATOR is an FDA 510(k)-cleared medical device (K071431) manufactured by Domino S.R.L.. This device is classified under the Physical Medicine specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 20, 2007. Regulation: 8.