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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Mechanical
510(k) Number K131336
Device Name TX WHEELCHAIR CHASSIS
Applicant
Jcm Seating Solutions, Ltd.
816 Congress Ave. Suite 1400
Austin,  TX  78701
Applicant Contact STUART R GOLDMAN
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number890.3850
Classification Product Code
IOR  
Date Received05/09/2013
Decision Date 10/28/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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