FDA 510(k)

折疊式輔助車輛（KD101）

K 號：K252502 · 2025-10-06

申請人Nanjing Kangni Smart Technology Co., Ltd.

決定日期2025-10-06

產品代碼INI

諮詢委員會PM

決定相當於

器材摘要

Folding Mobility Scooter (KD101) is the device name listed in this FDA 510(k) record. The listed applicant is Nanjing Kangni Smart Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-10-06 under 510(k) number K252502. 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 Folding Mobility Scooter (KD101)?

Folding Mobility Scooter (KD101) is a medical device that received FDA 510(k) clearance on 2025-10-06. The listed applicant is Nanjing Kangni Smart Technology Co., Ltd.. The 510(k) number is K252502.

When did Folding Mobility Scooter (KD101) receive FDA 510(k) clearance?

Folding Mobility Scooter (KD101) received FDA 510(k) clearance on 2025-10-06, under 510(k) number K252502.

Who is the listed applicant for Folding Mobility Scooter (KD101)?

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

What is the FDA product code for Folding Mobility Scooter (KD101)?

The FDA product code for Folding Mobility Scooter (KD101) is INI.

其他以 Nanjing Kangni Smart Technology 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。

K252494電動輪椅（KZ301B）

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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