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ITH — Equipment, Traction, Powered Class II

FDA Device Classification

Classification Details

Product Code
ITH
Device Class
Class II
Regulation Number
890.5900
Submission Type
Review Panel
PM
Medical Specialty
Physical Medicine
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K243775excite medical of tampa bayTrue Non-Surgical Spinal Decompression System (DRX9000-SL)July 18, 2025
K243366excite medical of tampa bayDRX9000C-SL Cervical Spinal Decompression SystemJune 18, 2025
K214037ergo-flex technologiesErgo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-TracFebruary 22, 2024
K222912zimmer medizinsystemec1TracMay 16, 2023
K151640enraf-noniusELTRAC 471October 16, 2015
K150695hollywogModpodAugust 13, 2015
K131983pivotal health solutionsITRAC CERVICAL TRACTION SYSTEMSeptember 10, 2014
K130249integrity life sciencesINTEGRITY SPINAL CARE SYSTEM 3.0February 6, 2014
K112074everyway medical instruments coEVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800February 1, 2012
K103248integra life sciencesINTEGRITY SPINAL CARE SYSTEMApril 5, 2011
K101889pivotal health solutionsDECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICEAugust 27, 2010
K091540mettler electronicsMTD 4000October 8, 2009
K081247ito coTM-400August 25, 2008
K072064therapeutic clinical technologiesGRAVILAX TRACTION SYSTEMApril 21, 2008
K073132north american medical corp (nam)MODEL D DISC FORCEApril 3, 2008
K073542pt productsCYCLETRAC CT-5000February 14, 2008
K071347vax-d medical technologiesVAX-D GENESIS G2 SYSTEMOctober 5, 2007
K063353circular traction supplyCTBOX CERVICAL/LUMBAR TRACTIONMarch 14, 2007
K060735axiom worldwideDRX9000 TRUE SPINAL DECOMPRESSION SYSTEMMay 26, 2006
K053223chattanooga groupTRITON/TRU-TRAC/TX/TRITON DTS TRACTIONFebruary 24, 2006