FDA 510(k)

電動輪椅（JJW-6001）

K 號：K240563 · 2024-10-08

決定日期2024-10-08

產品代碼ITI

諮詢委員會PM

決定相當於

器材摘要

Power Wheelchair (JJW-6001) is the device name listed in this FDA 510(k) record. The listed applicant is ZheJiang J&J Mobility Co., Ltd.. It received FDA 510(k) clearance on 2024-10-08 under 510(k) number K240563. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Power Wheelchair (JJW-6001)?

Power Wheelchair (JJW-6001) is a medical device that received FDA 510(k) clearance on 2024-10-08. The listed applicant is ZheJiang J&J Mobility Co., Ltd.. The 510(k) number is K240563.

When did Power Wheelchair (JJW-6001) receive FDA 510(k) clearance?

Power Wheelchair (JJW-6001) received FDA 510(k) clearance on 2024-10-08, under 510(k) number K240563.

Who is the listed applicant for Power Wheelchair (JJW-6001)?

The FDA 510(k) record lists ZheJiang J&J Mobility Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Power Wheelchair (JJW-6001)?

The FDA product code for Power Wheelchair (JJW-6001) is ITI.

其他以 ZheJiang J&J Mobility 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。

K253849電動輪椅（JJW-7002，JJW-7003）

相關器械（代碼：ITI）

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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