FDA 510(k)

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

Номер K: K214037 · 2024-02-22

Дата решения2024-02-22

Код продуктаITH

Консультативный комитетPM

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Связанные устройства (Код: 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

Официальный источник

Посмотреть в базе данных FDA →

Данные получены из открытого API FDA. Для получения наиболее актуальной и авторитетной информации всегда обращайтесь к официальным записям.