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FDA 510(k)

Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E)

K号: K250033 · 2025-04-07

申请人Guangzhou Pinzhi Medical Technology Co., Ltd.
决定日期2025-04-07
产品代码NUH
咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同

器械摘要

Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E) is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Pinzhi Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-04-07 under 510(k) number K250033. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E)?

Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E) is a medical device that received FDA 510(k) clearance on 2025-04-07. The listed applicant is Guangzhou Pinzhi Medical Technology Co., Ltd.. The 510(k) number is K250033.

When did Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E) receive FDA 510(k) clearance?

Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E) received FDA 510(k) clearance on 2025-04-07, under 510(k) number K250033.

Who is the listed applicant for Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E)?

The FDA 510(k) record lists Guangzhou Pinzhi Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E)?

The FDA product code for Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E) is NUH.

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：NUH）

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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