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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 K150574
Device Name Modular Power Positioning System
Applicant
Motion Concepts
84 Citation Dr., Unit #1
Concord,  CA L4K 3C1
Applicant Contact Dona Bhamra
Correspondent
Motion Concepts
84 Citation Dr., Unit #1
Concord,  CA L4K 3C1
Correspondent Contact Dona Bhamra
Regulation Number890.3860
Classification Product Code
ITI  
Date Received03/06/2015
Decision Date 06/30/2015
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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