FDA 510(k)

冷敷包Pro

K号: K230524 · 2024-01-19

申请人Chengdu Cryo-Push Medical Technology Co.,Ltd

决定日期2024-01-19

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

Cold Compression Wrap Pro is the device name listed in this FDA 510(k) record. The listed applicant is Chengdu Cryo-Push Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2024-01-19 under 510(k) number K230524. 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 Cold Compression Wrap Pro?

Cold Compression Wrap Pro is a medical device that received FDA 510(k) clearance on 2024-01-19. The listed applicant is Chengdu Cryo-Push Medical Technology Co.,Ltd. The 510(k) number is K230524.

When did Cold Compression Wrap Pro receive FDA 510(k) clearance?

Cold Compression Wrap Pro received FDA 510(k) clearance on 2024-01-19, under 510(k) number K230524.

Who is the listed applicant for Cold Compression Wrap Pro?

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

What is the FDA product code for Cold Compression Wrap Pro?

The FDA product code for Cold Compression Wrap Pro is IRP.

列明Chengdu Cryo-Push Medical Technology Co.,Ltd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。

K252386Hot and Cold Compression System (A02-C-032)K253076Cryopush 冷冻压缩设备（A02-P-001）K222669Cryopush 冷冻压缩设备

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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