FDA 510(k)

电动轮椅

K号: K242402 · 2024-11-18

申请人Zhejiang Zhonglei Medical Technology Co. , Ltd.

决定日期2024-11-18

产品代码ITI

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

Power wheelchair is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Zhonglei Medical Technology Co. , Ltd.. It received FDA 510(k) clearance on 2024-11-18 under 510(k) number K242402. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Power wheelchair?

Power wheelchair is a medical device that received FDA 510(k) clearance on 2024-11-18. The listed applicant is Zhejiang Zhonglei Medical Technology Co. , Ltd.. The 510(k) number is K242402.

When did Power wheelchair receive FDA 510(k) clearance?

Power wheelchair received FDA 510(k) clearance on 2024-11-18, under 510(k) number K242402.

Who is the listed applicant for Power wheelchair?

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

What is the FDA product code for Power wheelchair?

The FDA product code for Power wheelchair is ITI.

列明Zhejiang Zhonglei 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。

K242308电动轮椅 K241686电动轮椅 (N6101)

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。