FDA 510(k)

吳氏電動輪椅

K 號：K181163 · 2019-02-16

決定日期2019-02-16

產品代碼ITI

諮詢委員會PM

決定相當於

器材摘要

Wu's Powered Wheelchair is the device name listed in this FDA 510(k) record. The listed applicant is Wu'S Tech Co., Ltd.. It received FDA 510(k) clearance on 2019-02-16 under 510(k) number K181163. 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 Wu's Powered Wheelchair?

Wu's Powered Wheelchair is a medical device that received FDA 510(k) clearance on 2019-02-16. The listed applicant is Wu'S Tech Co., Ltd.. The 510(k) number is K181163.

When did Wu's Powered Wheelchair receive FDA 510(k) clearance?

Wu's Powered Wheelchair received FDA 510(k) clearance on 2019-02-16, under 510(k) number K181163.

Who is the listed applicant for Wu's Powered Wheelchair?

The FDA 510(k) record lists Wu'S Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Wu's Powered Wheelchair?

The FDA product code for Wu's Powered Wheelchair is ITI.

其他以 Wu'S Tech Co., Ltd. 為申請人之記錄

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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。

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