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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 K092936
Device Name AMIGO ESCORT 7.5, MODEL 760001 PHS
Applicant
Amigo Mobility Intl., Inc.
6693 Dixie Hwy.
Bridgeport,  MI  48722
Applicant Contact MIKE LABRAKE
Correspondent
Amigo Mobility Intl., Inc.
6693 Dixie Hwy.
Bridgeport,  MI  48722
Correspondent Contact MIKE LABRAKE
Regulation Number890.3860
Classification Product Code
ITI  
Date Received09/24/2009
Decision Date 12/04/2009
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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