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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 K152021
Device Name Pure Tilt
Applicant
Proactive Comfort, LLC
3901 Centerview Dr., Suite L
Chantilly,  VA  20151
Applicant Contact Tracy Augustine
Correspondent
Smith Assoicates
1468 Harwell Ave.,
Crofton,  MD  21114
Correspondent Contact EJ Smith
Regulation Number890.3850
Classification Product Code
IOR  
Date Received07/21/2015
Decision Date 03/31/2016
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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