FDA 510(k)

代步车（型号 X-01, X-02）

K号: K242975 · 2025-05-07

申请人Wuyi Aichi Industry & Trade Co., Ltd.

决定日期2025-05-07

产品代码INI

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

Mobility Scooter (Model X-01, X-02) is the device name listed in this FDA 510(k) record. The listed applicant is Wuyi Aichi Industry & Trade Co., Ltd.. It received FDA 510(k) clearance on 2025-05-07 under 510(k) number K242975. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Mobility Scooter (Model X-01, X-02)?

Mobility Scooter (Model X-01, X-02) is a medical device that received FDA 510(k) clearance on 2025-05-07. The listed applicant is Wuyi Aichi Industry & Trade Co., Ltd.. The 510(k) number is K242975.

When did Mobility Scooter (Model X-01, X-02) receive FDA 510(k) clearance?

Mobility Scooter (Model X-01, X-02) received FDA 510(k) clearance on 2025-05-07, under 510(k) number K242975.

Who is the listed applicant for Mobility Scooter (Model X-01, X-02)?

The FDA 510(k) record lists Wuyi Aichi Industry & Trade Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mobility Scooter (Model X-01, X-02)?

The FDA product code for Mobility Scooter (Model X-01, X-02) is INI.

列明Wuyi Aichi Industry & Trade 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。

K260237电动轮椅（X-12，X-14，X-17）

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。