FDA 510(k)

行動輪椅（型號X-01、X-02）

K 號：K242975 · 2025-05-07

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

決定日期2025-05-07

產品代碼INI

諮詢委員會PM

決定相當於

器材摘要

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.

常見問題

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.

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

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。

K260237行動輪椅（X-12、X-14、X-17）

相關器械（代碼：INI）

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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