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Bruno Independent Living Aids, Inc.
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REGAL MOTOTRIZED 3 WHEELED VEHICLE is an FDA 510(k)-cleared medical device (K011227) 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 10, 2001. Regulation: 8.