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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 K063474
Device Name ELECTRIC POWERED WHEELCHAIR MODEL-MINI (P14)
Applicant
Imc-Heart Way LLC
6140 Mid Metro Dr., Suite 6
Fort Myers,  FL  33912
Applicant Contact MICHAEL CHEN
Correspondent
Imc-Heart Way LLC
6140 Mid Metro Dr., Suite 6
Fort Myers,  FL  33912
Correspondent Contact MICHAEL CHEN
Regulation Number890.3860
Classification Product Code
ITI  
Date Received11/16/2006
Decision Date 12/22/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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