FDA 510(k)

Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08

Номер K: K191334 · 2020-05-29

Дата решения2020-05-29

Код продуктаIPL

Консультативный комитетPM

РешениеSubstantially Equivalent

Описание устройства

Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08 is the device name listed in this FDA 510(k) record. The listed applicant is Matia Robotics (Us), Inc.. It received FDA 510(k) clearance on 2020-05-29 under 510(k) number K191334. The device is classified under product code IPL. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08?

Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08 is a medical device that received FDA 510(k) clearance on 2020-05-29. The listed applicant is Matia Robotics (Us), Inc.. The 510(k) number is K191334.

When did Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08 receive FDA 510(k) clearance?

Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08 received FDA 510(k) clearance on 2020-05-29, under 510(k) number K191334.

Who is the listed applicant for Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08?

The FDA 510(k) record lists Matia Robotics (Us), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08?

The FDA product code for Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08 is IPL.

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: IPL)

K243783Walking rehabilitation training electric wheelchair (ZW518)Shenzhen Zuowei Technology Co., Ltd.K202728Action Trackchair HawkAction Manufacturing, Inc.K203761ParaMotionPowerbasetec GmbH K190682Explorer MiniPermobil AB K191874F5 Corpus VSPermobil AB K182257UPnRIDEUpnride Robotics , Ltd.

Официальный источник

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