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FDA 510(k)

e-Throne 折疊輪椅,型號:ET-12F22

K 號:K191105 · 2022-01-21

決定日期2022-01-21
產品代碼ITI
諮詢委員會PM
決定相當於

器材摘要

e-Throne Folding Wheelchair, Model: ET-12F22 is the device name listed in this FDA 510(k) record. The listed applicant is Golden Motor Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-01-21 under 510(k) number K191105. 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 e-Throne Folding Wheelchair, Model: ET-12F22?

e-Throne Folding Wheelchair, Model: ET-12F22 is a medical device that received FDA 510(k) clearance on 2022-01-21. The listed applicant is Golden Motor Technology Co., Ltd.. The 510(k) number is K191105.

When did e-Throne Folding Wheelchair, Model: ET-12F22 receive FDA 510(k) clearance?

e-Throne Folding Wheelchair, Model: ET-12F22 received FDA 510(k) clearance on 2022-01-21, under 510(k) number K191105.

Who is the listed applicant for e-Throne Folding Wheelchair, Model: ET-12F22?

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

What is the FDA product code for e-Throne Folding Wheelchair, Model: ET-12F22?

The FDA product code for e-Throne Folding Wheelchair, Model: ET-12F22 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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