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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 K131983
Device Name ITRAC CERVICAL TRACTION SYSTEM
Applicant
PIVOTAL HEALTH SOLUTIONS
724 OAKWOOD RD
WATERTOWN,  SD  57201
Applicant Contact AARON TVEDT
Correspondent
PIVOTAL HEALTH SOLUTIONS
724 OAKWOOD RD
WATERTOWN,  SD  57201
Correspondent Contact AARON TVEDT
Regulation Number890.5900
Classification Product Code
ITH  
Subsequent Product Codes
ILZ   IRS  
Date Received06/28/2013
Decision Date 09/10/2014
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
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