FDA 510(k)空气压缩按摩器（型号 LF-FT003）
K号: K213000 · 2021-11-15
决定日期2021-11-15
产品代码IRP
咨询委员会PM
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决定实质等同
器械摘要
Air Compression Massager (Model LF-FT003) is the device name listed in this FDA 510(k) record. The listed applicant is Wenzhou Lingfeng Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-11-15 under 510(k) number K213000. 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 Massager (Model LF-FT003)?
Air Compression Massager (Model LF-FT003) is a medical device that received FDA 510(k) clearance on 2021-11-15. The listed applicant is Wenzhou Lingfeng Electronic Technology Co., Ltd.. The 510(k) number is K213000.
When did Air Compression Massager (Model LF-FT003) receive FDA 510(k) clearance?
Air Compression Massager (Model LF-FT003) received FDA 510(k) clearance on 2021-11-15, under 510(k) number K213000.
Who is the listed applicant for Air Compression Massager (Model LF-FT003)?
The FDA 510(k) record lists Wenzhou Lingfeng Electronic Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Air Compression Massager (Model LF-FT003)?
The FDA product code for Air Compression Massager (Model LF-FT003) 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。
列明Wenzhou Lingfeng 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。
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）
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.