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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 K214037
Device Name Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac
Applicant
Ergo-Flex Technologies, LLC
13622 Poplar Cir.
Conroe,  TX  77304
Applicant Contact Linda Anderson
Correspondent
Texas Applied Biomedical Services
12101 Cullen Blve. Suite A
Houston,  TX  77047
Correspondent Contact M. Joyce Heinrich
Regulation Number890.5900
Classification Product Code
ITH  
Subsequent Product Codes
ILZ   IRO   IRT  
Date Received12/23/2021
Decision Date 02/22/2024
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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