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FDA 510(k)

Powerpress康复单元

K号: K202044 · 2020-10-21

申请人Hanuri Distribution, Inc.
决定日期2020-10-21
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

Powerpress Recovery Unit is the device name listed in this FDA 510(k) record. The listed applicant is Hanuri Distribution, Inc.. It received FDA 510(k) clearance on 2020-10-21 under 510(k) number K202044. 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 Powerpress Recovery Unit?

Powerpress Recovery Unit is a medical device that received FDA 510(k) clearance on 2020-10-21. The listed applicant is Hanuri Distribution, Inc.. The 510(k) number is K202044.

When did Powerpress Recovery Unit receive FDA 510(k) clearance?

Powerpress Recovery Unit received FDA 510(k) clearance on 2020-10-21, under 510(k) number K202044.

Who is the listed applicant for Powerpress Recovery Unit?

The FDA 510(k) record lists Hanuri Distribution, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powerpress Recovery Unit?

The FDA product code for Powerpress Recovery Unit 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。

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