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FDA 510(k)

冷冻-热疗压缩装置 (FGK002)

K号: K222136 · 2023-03-08

申请人Suzhou Microport Rehabtech (Group) Co., Ltd.
决定日期2023-03-08
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

Cryo-Thermo Compression Device (FGK002) is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Microport Rehabtech (Group) Co., Ltd.. It received FDA 510(k) clearance on 2023-03-08 under 510(k) number K222136. 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 Cryo-Thermo Compression Device (FGK002)?

Cryo-Thermo Compression Device (FGK002) is a medical device that received FDA 510(k) clearance on 2023-03-08. The listed applicant is Suzhou Microport Rehabtech (Group) Co., Ltd.. The 510(k) number is K222136.

When did Cryo-Thermo Compression Device (FGK002) receive FDA 510(k) clearance?

Cryo-Thermo Compression Device (FGK002) received FDA 510(k) clearance on 2023-03-08, under 510(k) number K222136.

Who is the listed applicant for Cryo-Thermo Compression Device (FGK002)?

The FDA 510(k) record lists Suzhou Microport Rehabtech (Group) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cryo-Thermo Compression Device (FGK002)?

The FDA product code for Cryo-Thermo Compression Device (FGK002) 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

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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