FDA 510(k)

AIR压缩靴1018195，1018196

K号: K251531 · 2025-10-30

决定日期2025-10-30

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

AIR COMPRESSION BOOTS 1018195,1018196 is the device name listed in this FDA 510(k) record. The listed applicant is Merchsource, LLC. It received FDA 510(k) clearance on 2025-10-30 under 510(k) number K251531. 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 AIR COMPRESSION BOOTS 1018195,1018196?

AIR COMPRESSION BOOTS 1018195,1018196 is a medical device that received FDA 510(k) clearance on 2025-10-30. The listed applicant is Merchsource, LLC. The 510(k) number is K251531.

When did AIR COMPRESSION BOOTS 1018195,1018196 receive FDA 510(k) clearance?

AIR COMPRESSION BOOTS 1018195,1018196 received FDA 510(k) clearance on 2025-10-30, under 510(k) number K251531.

Who is the listed applicant for AIR COMPRESSION BOOTS 1018195,1018196?

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

What is the FDA product code for AIR COMPRESSION BOOTS 1018195,1018196?

The FDA product code for AIR COMPRESSION BOOTS 1018195,1018196 is IRP.

列明Merchsource, 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。

K252093光疗面膜（1019055）K252096光疗颈部护理面膜（1019135）

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

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。