FDA 510(k)

按摩压缩靴

K号: K201645 · 2020-09-15

决定日期2020-09-15

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

Massage Compression Boots is the device name listed in this FDA 510(k) record. The listed applicant is Jkh USA, LLC. It received FDA 510(k) clearance on 2020-09-15 under 510(k) number K201645. 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 Massage Compression Boots?

Massage Compression Boots is a medical device that received FDA 510(k) clearance on 2020-09-15. The listed applicant is Jkh USA, LLC. The 510(k) number is K201645.

When did Massage Compression Boots receive FDA 510(k) clearance?

Massage Compression Boots received FDA 510(k) clearance on 2020-09-15, under 510(k) number K201645.

Who is the listed applicant for Massage Compression Boots?

The FDA 510(k) record lists Jkh USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Massage Compression Boots?

The FDA product code for Massage Compression Boots is IRP.

列明Jkh USA, LLC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。

K203636PlusCare 温度探头，皮肤类型：PT2252-AS，PTHP-AS，PTMQ-AS，PTSW-AS，PTSM-15AS，PTSL-AS，PTMR-AS；直肠类型：PT2252-AG，PTHP-AG，PTMQ-AG，PTSW-AG，PTSM-15AG，PTSL-AG，PTMR-AG K203635患者监护电缆 K203652血压计，U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, 血压计，U1885S, U1885D, U1880S, U1880D, U1886S, U1886D, 血压计，U1869S, U1869D, U1889S, U1889D, U1884S, U1884D, 血压计，U1710S, U1720S, U1730S,U1740S, U1750S, U1760S, 血压计，U1770S, U1790s, U1710D, U1720D, U1730D, U1740D K202851Spo2传感器 K201470一次性医用口罩 K182671Medi-Direct TENS 笔

查看所有 9 个设备 →

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, LLC K260529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 Saúde K254200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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