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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vehicle, Motorized 3-Wheeled
510(k) Number K981121
Device Name AMIGO RT
Applicant
AMIGO MOBILITY INTL., INC.
6693 DIXIE HWY.
BRIDGEPORT,  MI  48722
Applicant Contact ANDREA J LUPO
Correspondent
AMIGO MOBILITY INTL., INC.
6693 DIXIE HWY.
BRIDGEPORT,  MI  48722
Correspondent Contact ANDREA J LUPO
Regulation Number890.3800
Classification Product Code
INI  
Date Received03/27/1998
Decision Date 06/30/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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