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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Powered
510(k) Number K011227
Device Name REGAL MOTOTRIZED 3 WHEELED VEHICLE
Applicant
Bruno Independent Living Aids, Inc.
1780 Executive Dr.
P.O. Box 84
Oconomowoc,  WI  53066
Applicant Contact RICHARD A KELLER
Correspondent
Bruno Independent Living Aids, Inc.
1780 Executive Dr.
P.O. Box 84
Oconomowoc,  WI  53066
Correspondent Contact RICHARD A KELLER
Regulation Number890.3860
Classification Product Code
ITI  
Date Received04/23/2001
Decision Date 05/11/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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