510(k) K921647

REGAL MOTORIZIED 3 WHEELED VEHICLE by Bruno Independent Living Aids, Inc. — Product Code INI

K921647 is an FDA 510(k) premarket notification submitted by Bruno Independent Living Aids, Inc. for the device "REGAL MOTORIZIED 3 WHEELED VEHICLE". The FDA issued a decision of Substantially Equivalent on May 4, 1992. The device falls under product code INI (Vehicle, Motorized 3-Wheeled), a Class II device regulated under 21 CFR 890.3800. Bruno Independent Living Aids, Inc. has at least 10 other 510(k) clearances on record.