FDA 510(k)

电动轮椅（X-12，X-14，X-17）

K号: K260237 · 2026-04-22

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

决定日期2026-04-22

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 (X-12, X-14, X-17) is the device name listed in this FDA 510(k) record. The listed applicant is Wuyi Aichi Industry and Trade Co., Ltd.. It received FDA 510(k) clearance on 2026-04-22 under 510(k) number K260237. 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 (X-12, X-14, X-17)?

Mobility Scooter (X-12, X-14, X-17) is a medical device that received FDA 510(k) clearance on 2026-04-22. The listed applicant is Wuyi Aichi Industry and Trade Co., Ltd.. The 510(k) number is K260237.

When did Mobility Scooter (X-12, X-14, X-17) receive FDA 510(k) clearance?

Mobility Scooter (X-12, X-14, X-17) received FDA 510(k) clearance on 2026-04-22, under 510(k) number K260237.

Who is the listed applicant for Mobility Scooter (X-12, X-14, X-17)?

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

What is the FDA product code for Mobility Scooter (X-12, X-14, X-17)?

The FDA product code for Mobility Scooter (X-12, X-14, X-17) is INI.

列明Wuyi Aichi Industry and 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。

K242975代步车（型号 X-01, X-02）

官方来源

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