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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 K023426
Device Name TRX VERTICAL POSITIONER
Applicant
Motion Concepts
84 Citation Dr.
Concord, Ontario,  CA L4K 3C1
Applicant Contact DAVID CIOLFE
Correspondent
Motion Concepts
84 Citation Dr.
Concord, Ontario,  CA L4K 3C1
Correspondent Contact DAVID CIOLFE
Regulation Number890.3860
Classification Product Code
ITI  
Date Received10/11/2002
Decision Date 11/21/2002
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
Recalls CDRH Recalls
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