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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 K992619
Device Name AMIGO MODEL 680000 (AMIGO EXCITE F 350)
Applicant
Amigo Mobility Intl., Inc.
6693 Dixie Hwy.
Bridgeport,  MI  48722
Applicant Contact DALE CONFER
Correspondent
Amigo Mobility Intl., Inc.
6693 Dixie Hwy.
Bridgeport,  MI  48722
Correspondent Contact DALE CONFER
Regulation Number890.3860
Classification Product Code
ITI  
Date Received08/04/1999
Decision Date 10/25/1999
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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