FDA 510(k)

压力治疗系统 PT1003

K号: K181409 · 2019-02-19

决定日期2019-02-19

产品代码IRP

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决定实质等同

器械摘要

Pressure Therapy System PT1003 is the device name listed in this FDA 510(k) record. The listed applicant is Xiamen Senyang Co., Ltd.. It received FDA 510(k) clearance on 2019-02-19 under 510(k) number K181409. 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 Pressure Therapy System PT1003?

Pressure Therapy System PT1003 is a medical device that received FDA 510(k) clearance on 2019-02-19. The listed applicant is Xiamen Senyang Co., Ltd.. The 510(k) number is K181409.

When did Pressure Therapy System PT1003 receive FDA 510(k) clearance?

Pressure Therapy System PT1003 received FDA 510(k) clearance on 2019-02-19, under 510(k) number K181409.

Who is the listed applicant for Pressure Therapy System PT1003?

The FDA 510(k) record lists Xiamen Senyang Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pressure Therapy System PT1003?

The FDA product code for Pressure Therapy System PT1003 is IRP.

列明Xiamen Senyang Co., Ltd.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。

K192358压力治疗系统 PT1003 K161907压力治疗系统

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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