REGAL MOTORIZIED 3 WHEELED VEHICLE

REGAL MOTORIZIED 3 WHEELED VEHICLE is an FDA 510(k)-cleared medical device (K921647) manufactured by Bruno Independent Living Aids, 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 May 3, 1992. Regulation: 8.