FDA 510(k)

行動輪椅（X-12、X-14、X-17）

K 號：K260237 · 2026-04-22

申請人Wuyi Aichi Industry and Trade Co., Ltd.

決定日期2026-04-22

產品代碼INI

諮詢委員會PM

決定相當於

器材摘要

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.

常見問題

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.

其他以 Wuyi Aichi Industry and Trade Co., Ltd. 為申請人之記錄

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相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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