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FDA 510(k)

Cryo Sport 2.0 (AVA 501)

K号: K252396 · 2026-05-29

申请人Avanutri Equipamentos DE Saúde
决定日期2026-05-29
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

Cryo Sport 2.0 (AVA 501) is the device name listed in this FDA 510(k) record. The listed applicant is Avanutri Equipamentos DE Saúde. It received FDA 510(k) clearance on 2026-05-29 under 510(k) number K252396. 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 Cryo Sport 2.0 (AVA 501)?

Cryo Sport 2.0 (AVA 501) is a medical device that received FDA 510(k) clearance on 2026-05-29. The listed applicant is Avanutri Equipamentos DE Saúde. The 510(k) number is K252396.

When did Cryo Sport 2.0 (AVA 501) receive FDA 510(k) clearance?

Cryo Sport 2.0 (AVA 501) received FDA 510(k) clearance on 2026-05-29, under 510(k) number K252396.

Who is the listed applicant for Cryo Sport 2.0 (AVA 501)?

The FDA 510(k) record lists Avanutri Equipamentos DE Saúde as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cryo Sport 2.0 (AVA 501)?

The FDA product code for Cryo Sport 2.0 (AVA 501) 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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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.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.K253064空气压力治疗系统（VU-IPC8M）；空气压力治疗系统（VU-IPC6M）；空气压力治疗系统（VU-IPC4X）Xiamen Weiyou Intelligent Technology Co., Ltd.

官方来源

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