FDA 510(k)Air Relax Pro型号AR-4.0
K号: K212491 · 2021-09-02
决定日期2021-09-02
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 Relax Pro Model AR-4.0 is the device name listed in this FDA 510(k) record. The listed applicant is Diode Art Engineering Doing Business AS Air Relax. It received FDA 510(k) clearance on 2021-09-02 under 510(k) number K212491. 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 Relax Pro Model AR-4.0?
Air Relax Pro Model AR-4.0 is a medical device that received FDA 510(k) clearance on 2021-09-02. The listed applicant is Diode Art Engineering Doing Business AS Air Relax. The 510(k) number is K212491.
When did Air Relax Pro Model AR-4.0 receive FDA 510(k) clearance?
Air Relax Pro Model AR-4.0 received FDA 510(k) clearance on 2021-09-02, under 510(k) number K212491.
Who is the listed applicant for Air Relax Pro Model AR-4.0?
The FDA 510(k) record lists Diode Art Engineering Doing Business AS Air Relax as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Air Relax Pro Model AR-4.0?
The FDA product code for Air Relax Pro Model AR-4.0 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Diode Art Engineering Doing Business AS Air Relax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。
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.