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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name equipment, traction, powered
510(k) Number K112074
Model EVER-TRAC ET-800
Device Name EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800
Original Applicant
EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
845 aronson lake court
roswell,  GA  30075
Original Contact jay mansour
Regulation Number890.5900
Classification Product Code
ITH  
Date Received07/20/2011
Decision Date 02/01/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Physical Medicine
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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