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FDA 510(k)

Therm-X Pro, Therm-X AT, Therm-X Pro Athlete

K号: K181149 · 2018-08-03

申请人Zenith Technical Innovations
决定日期2018-08-03
产品代码IRP
咨询委员会PM 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。
决定实质等同

器械摘要

Therm-X Pro, Therm-X AT, Therm-X Pro Athlete is the device name listed in this FDA 510(k) record. The listed applicant is Zenith Technical Innovations. It received FDA 510(k) clearance on 2018-08-03 under 510(k) number K181149. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Therm-X Pro, Therm-X AT, Therm-X Pro Athlete?

Therm-X Pro, Therm-X AT, Therm-X Pro Athlete is a medical device that received FDA 510(k) clearance on 2018-08-03. The listed applicant is Zenith Technical Innovations. The 510(k) number is K181149.

When did Therm-X Pro, Therm-X AT, Therm-X Pro Athlete receive FDA 510(k) clearance?

Therm-X Pro, Therm-X AT, Therm-X Pro Athlete received FDA 510(k) clearance on 2018-08-03, under 510(k) number K181149.

Who is the listed applicant for Therm-X Pro, Therm-X AT, Therm-X Pro Athlete?

The FDA 510(k) record lists Zenith Technical Innovations as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Therm-X Pro, Therm-X AT, Therm-X Pro Athlete?

The FDA product code for Therm-X Pro, Therm-X AT, Therm-X Pro Athlete is IRP.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Zenith Technical Innovations为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K240125Therm-X（家用）；Therm-X（AT）K231912Therm-XK193550Therm-XK190854Therm-X

相关器械（代码：IRP）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K260944玛娜冷敷压缩系统Manamed, LLCK260529空气压缩按摩器（HY-1165）Xiamen High Top Electronic Technology Co., Ltd.K260948空气压缩按摩器（EP30B001 I）Wavepulse (Xiamen) Healthcare Technology Co., Ltd.K253919冷冻和热疗系统Xiamen Weiyou Intelligent Technology Co., Ltd.K252396Cryo Sport 2.0 (AVA 501)Avanutri Equipamentos DE SaúdeK254200空气压缩腿部按摩器（LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1, LF-FT005-1, LF-FT006-1, LF-FT007, LF-FT008, LF-FT009, LF-FT010, LF-FT011, LF-FT012, LF-FT013, LF-FT014, LF-FT015, LF-FT016, UM-01, UM-02, UM-03, UM-03-1, UM-04-1, UM-05-1, UM-06-1, UM-07, UM-08, UM-09, UM-10, UM-11, UM-12, UM-13, UM-14, UM-15, UM-16, AI-01, AI-02, AI-03, AI-04, AI-05, AI-06, AI01, AI02, AI03, AI-07, AI-08, AI-09, AI-10, AI-11, AI-12, AI-13, AI-14）Wenzhou Lingfeng Electronic Technology Co., Ltd.

官方来源

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