FDA 510(k)Rapid 重启压缩治疗系统
K号: K182668 · 2018-12-14
决定日期2018-12-14
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
Rapid Reboot Compression Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Rapid Reboot Recovery Products, LLC. It received FDA 510(k) clearance on 2018-12-14 under 510(k) number K182668. 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 Rapid Reboot Compression Therapy System?
Rapid Reboot Compression Therapy System is a medical device that received FDA 510(k) clearance on 2018-12-14. The listed applicant is Rapid Reboot Recovery Products, LLC. The 510(k) number is K182668.
When did Rapid Reboot Compression Therapy System receive FDA 510(k) clearance?
Rapid Reboot Compression Therapy System received FDA 510(k) clearance on 2018-12-14, under 510(k) number K182668.
Who is the listed applicant for Rapid Reboot Compression Therapy System?
The FDA 510(k) record lists Rapid Reboot Recovery Products, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Rapid Reboot Compression Therapy System?
The FDA product code for Rapid Reboot Compression Therapy System 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Rapid Reboot Recovery Products, 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。
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.