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FDA 510(k)

電動輪椅(ZS-EW8026)

K 號:K254206 · 2026-03-27

決定日期2026-03-27
產品代碼ITI
諮詢委員會PM
決定相當於

器材摘要

Power wheelchair (ZS-EW8026) is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Zhishan Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-03-27 under 510(k) number K254206. 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 (ZS-EW8026)?

Power wheelchair (ZS-EW8026) is a medical device that received FDA 510(k) clearance on 2026-03-27. The listed applicant is Ningbo Zhishan Medical Technology Co., Ltd.. The 510(k) number is K254206.

When did Power wheelchair (ZS-EW8026) receive FDA 510(k) clearance?

Power wheelchair (ZS-EW8026) received FDA 510(k) clearance on 2026-03-27, under 510(k) number K254206.

Who is the listed applicant for Power wheelchair (ZS-EW8026)?

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

What is the FDA product code for Power wheelchair (ZS-EW8026)?

The FDA product code for Power wheelchair (ZS-EW8026) is ITI.

相關臨床試驗

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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。

官方來源

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