FDA 510(k)

空气压缩腿部按摩器 HY-1117A

K号: K212713 · 2022-01-18

申请人Xiamen High Top Electronic Technology Co., Ltd.

决定日期2022-01-18

产品代码IRP

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决定实质等同

器械摘要

Air compression leg massager HY-1117A is the device name listed in this FDA 510(k) record. The listed applicant is Xiamen High Top Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-01-18 under 510(k) number K212713. 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 leg massager HY-1117A?

Air compression leg massager HY-1117A is a medical device that received FDA 510(k) clearance on 2022-01-18. The listed applicant is Xiamen High Top Electronic Technology Co., Ltd.. The 510(k) number is K212713.

When did Air compression leg massager HY-1117A receive FDA 510(k) clearance?

Air compression leg massager HY-1117A received FDA 510(k) clearance on 2022-01-18, under 510(k) number K212713.

Who is the listed applicant for Air compression leg massager HY-1117A?

FDA 510(k)记录将厦门高顶电子科技有限公司列为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for Air compression leg massager HY-1117A?

The FDA product code for Air compression leg massager HY-1117A is IRP.

列明Xiamen High Top Electronic Technology 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。

K260529空气压缩按摩器（HY-1165）

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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