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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 K990544
Device Name TRX-CG POWER TILT AND RECLINE SYSTEM
Applicant
Motion Concepts
101 Bartley Dr.
Toronto, Ontario,  CA M4A 1C9
Applicant Contact ALLAN BOYD
Correspondent
Motion Concepts
101 Bartley Dr.
Toronto, Ontario,  CA M4A 1C9
Correspondent Contact ALLAN BOYD
Regulation Number890.3860
Classification Product Code
ITI  
Date Received02/22/1999
Decision Date 04/08/1999
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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