Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac
K-Number: K214037 · 2024-02-22
ApplicantErgo-Flex Technologies, LLC
Decision Date2024-02-22
Product CodeITH
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac is a medical device manufactured by Ergo-Flex Technologies, LLC. It received FDA 510(k) clearance on 2024-02-22 under approval number K214037. The device is classified under product code ITH. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac?
Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac is a medical device that received FDA 510(k) clearance on 2024-02-22. It is manufactured by Ergo-Flex Technologies, LLC. The 510(k) number is K214037.
When was Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac approved by the FDA?
Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac received FDA 510(k) clearance on 2024-02-22, under approval number K214037.
What company makes Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac?
Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac is manufactured by Ergo-Flex Technologies, LLC.
What is the FDA product code for Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac?
The FDA product code for Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac is ITH.
Related Devices (Code: ITH)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.