K-number	K214037
Device name	Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac
Applicant	Ergo-Flex Technologies, LLC
Product code	ITH
Device class	Class II
Decision date	Feb 22, 2024
Decision	Substantially Equivalent
Regulation	890.5900

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View the full FDA submission: accessdata.fda.gov

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Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac

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