FDA 510(k)

電動輪椅（JJW-7002，JJW-7003）

K 號：K253849 · 2026-03-20

決定日期2026-03-20

產品代碼ITI

諮詢委員會PM

決定相當於

器材摘要

Electric wheelchair (JJW-7002, JJW-7003) 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 2026-03-20 under 510(k) number K253849. 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 Electric wheelchair (JJW-7002, JJW-7003)?

Electric wheelchair (JJW-7002, JJW-7003) is a medical device that received FDA 510(k) clearance on 2026-03-20. The listed applicant is ZheJiang J&J Mobility Co., Ltd.. The 510(k) number is K253849.

When did Electric wheelchair (JJW-7002, JJW-7003) receive FDA 510(k) clearance?

Electric wheelchair (JJW-7002, JJW-7003) received FDA 510(k) clearance on 2026-03-20, under 510(k) number K253849.

Who is the listed applicant for Electric wheelchair (JJW-7002, JJW-7003)?

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 Electric wheelchair (JJW-7002, JJW-7003)?

The FDA product code for Electric wheelchair (JJW-7002, JJW-7003) 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。

K240563電動輪椅（JJW-6001）

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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官方來源

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