ORTHO DEVELOPMENT ORION-I EMF SYSTEM

ORTHO DEVELOPMENT ORION-I EMF SYSTEM is an FDA 510(k)-cleared medical device (K012129) manufactured by Ortho Development Corp.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 21, 2001. Regulation: 8.