THE SPORTSTER (ELECTRIFIED WHEELCHAIR)

THE SPORTSTER (ELECTRIFIED WHEELCHAIR) is an FDA 510(k)-cleared medical device (K853918) manufactured by Amigo Sales, Inc.. 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 January 12, 1986. Regulation: 8.