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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 K853918
Device Name THE SPORTSTER (ELECTRIFIED WHEELCHAIR)
Applicant
Amigo Sales, Inc.
6693 Dixie Hwy.
Bridgeport,  MI  48722
Applicant Contact WARREN C LIGHT
Correspondent
Amigo Sales, Inc.
6693 Dixie Hwy.
Bridgeport,  MI  48722
Correspondent Contact WARREN C LIGHT
Regulation Number890.3800
Classification Product Code
INI  
Date Received09/23/1985
Decision Date 01/13/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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