OPTI-RIDER DELUXE

OPTI-RIDER DELUXE is an FDA 510(k)-cleared medical device (K033116) manufactured by Hansung Econet Co., Ltd.. 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 April 11, 2004. Regulation: 8.