電動輪椅（AL-208S-063）
K 號：K253340 · 2026-04-03
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器材摘要
Electric Wheelchair (AL-208S-063) is the device name listed in this FDA 510(k) record. The listed applicant is Zhongshan A&J Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2026-04-03 under 510(k) number K253340. 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 (AL-208S-063)?
Electric Wheelchair (AL-208S-063) is a medical device that received FDA 510(k) clearance on 2026-04-03. The listed applicant is Zhongshan A&J Medical Equipment Co., Ltd.. The 510(k) number is K253340.
When did Electric Wheelchair (AL-208S-063) receive FDA 510(k) clearance?
Electric Wheelchair (AL-208S-063) received FDA 510(k) clearance on 2026-04-03, under 510(k) number K253340.
Who is the listed applicant for Electric Wheelchair (AL-208S-063)?
The FDA 510(k) record lists Zhongshan A&J Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Electric Wheelchair (AL-208S-063)?
The FDA product code for Electric Wheelchair (AL-208S-063) is ITI.
相關臨床試驗
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。
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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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