FDA.reportPublic FDA data

510(k) K214037

Device
Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac
Applicant
Ergo-Flex Technologies, LLC
510(k) number
K214037
Product code
ITH
Decision
Substantially Equivalent (SESE)
Decision date
2024-02-22
Date received
2021-12-23
Regulation
890.5900
Classification name
Equipment, Traction, Powered
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Linda Anderson
Address
13622 Poplar Cir. Conroe TX US 77304 77304

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K130249INTEGRITY SPINAL CARE SYSTEM 3.0Integrity Life Sciences2014-02-06
K112074EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800Everyway Medical Instruments Co.,Ltd2012-02-01
K103248INTEGRITY SPINAL CARE SYSTEMIntegra Life Sciences2011-04-05
K101889DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICEPivotal Health Solutions2010-08-27
K091540MTD 4000Mettler Electronics Corp.2009-10-08
K081247TM-400Ito Co., Ltd.2008-08-25
K072064GRAVILAX TRACTION SYSTEMTherapeutic Clinical Technologies, Inc.2008-04-21
K073132MODEL D DISC FORCENorth American Medical Corp (Nam)2008-04-03
K073542CYCLETRAC CT-5000Pt Products, LLC2008-02-14