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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 K092225
Device Name AMYPOWER ALL TRACK SERIES POWER WHEELCHAIR
Applicant
Amylior, Inc.
1650 Chicoine
Vaudreuil- Dorian
Quebec,  CA J7V 8P2
Applicant Contact ERIC DUGAS
Correspondent
Amylior, Inc.
1650 Chicoine
Vaudreuil- Dorian
Quebec,  CA J7V 8P2
Correspondent Contact ERIC DUGAS
Regulation Number890.3860
Classification Product Code
ITI  
Date Received07/23/2009
Decision Date 10/09/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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