FDA 510(k)

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

Numéro K : K214037 · 2024-02-22

Date de décision2024-02-22

Code produitITH

Comité consultatifPM

DécisionSubstantially Equivalent

Résumé du dispositif

Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac is the device name listed in this FDA 510(k) record. The listed applicant is Ergo-Flex Technologies, LLC. It received FDA 510(k) clearance on 2024-02-22 under 510(k) number K214037. The device is classified under product code ITH. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

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. The listed applicant is Ergo-Flex Technologies, LLC. The 510(k) number is K214037.

When did Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac receive FDA 510(k) clearance?

Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac received FDA 510(k) clearance on 2024-02-22, under 510(k) number K214037.

Who is the listed applicant for Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac?

The FDA 510(k) record lists Ergo-Flex Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

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.

Essais cliniques associés

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Dispositifs connexes (Code : ITH)

K243775True Non-Surgical Spinal Decompression System (DRX9000-SL)Excite Medical of Tampa Bay, LLC K243366DRX9000C-SL Cervical Spinal Decompression SystemExcite Medical of Tampa Bay, LLC K222912c1TracZimmer Medizinsysteme GmbH

Source officielle

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