i3可折疊移動輪椅
K 號：K191356 · 2022-01-11
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器材摘要
i3 Foldable Mobility Scooter is the device name listed in this FDA 510(k) record. The listed applicant is Puc Perfect Union Co., Ltd.. It received FDA 510(k) clearance on 2022-01-11 under 510(k) number K191356. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the i3 Foldable Mobility Scooter?
i3 Foldable Mobility Scooter is a medical device that received FDA 510(k) clearance on 2022-01-11. The listed applicant is Puc Perfect Union Co., Ltd.. The 510(k) number is K191356.
When did i3 Foldable Mobility Scooter receive FDA 510(k) clearance?
i3 Foldable Mobility Scooter received FDA 510(k) clearance on 2022-01-11, under 510(k) number K191356.
Who is the listed applicant for i3 Foldable Mobility Scooter?
The FDA 510(k) record lists Puc Perfect Union Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for i3 Foldable Mobility Scooter?
The FDA product code for i3 Foldable Mobility Scooter is INI.
相關臨床試驗
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相關器械（代碼：INI）
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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