FDA 510(k)

Ergo-Flex Technologies 回軌 (BOTGEN1) 及頸椎軌跡 (Cervi-Trac)

K 號：K214037 · 2024-02-22

決定日期2024-02-22

產品代碼ITH

諮詢委員會PM

決定相當於

器材摘要

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.

常見問題

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.

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器材摘要

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相關器械（代碼：ITH）

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