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FDA 510(k)

腿部和足部空气波压力治疗设备

K号: K223464 · 2023-03-14

申请人Zhangzhou Easepal Innovation CO , Ltd.
决定日期2023-03-14
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

Leg and Foot Air Wave Pressure Therapy Device is the device name listed in this FDA 510(k) record. The listed applicant is Zhangzhou Easepal Innovation CO , Ltd.. It received FDA 510(k) clearance on 2023-03-14 under 510(k) number K223464. 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 Leg and Foot Air Wave Pressure Therapy Device?

Leg and Foot Air Wave Pressure Therapy Device is a medical device that received FDA 510(k) clearance on 2023-03-14. The listed applicant is Zhangzhou Easepal Innovation CO , Ltd.. The 510(k) number is K223464.

When did Leg and Foot Air Wave Pressure Therapy Device receive FDA 510(k) clearance?

Leg and Foot Air Wave Pressure Therapy Device received FDA 510(k) clearance on 2023-03-14, under 510(k) number K223464.

Who is the listed applicant for Leg and Foot Air Wave Pressure Therapy Device?

The FDA 510(k) record lists Zhangzhou Easepal Innovation CO , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Leg and Foot Air Wave Pressure Therapy Device?

The FDA product code for Leg and Foot Air Wave Pressure Therapy Device is IRP.

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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。

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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。

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