FDA 510(k)

電動輪椅，WT-T4QP2

K 號：K222729 · 2023-03-28

決定日期2023-03-28

產品代碼INI

諮詢委員會PM

決定相當於

器材摘要

Electrical Scooter, WT-T4QP2 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 2023-03-28 under 510(k) number K222729. 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 Electrical Scooter, WT-T4QP2?

Electrical Scooter, WT-T4QP2 is a medical device that received FDA 510(k) clearance on 2023-03-28. The listed applicant is Wu’S Tech Co., Ltd.. The 510(k) number is K222729.

When did Electrical Scooter, WT-T4QP2 receive FDA 510(k) clearance?

Electrical Scooter, WT-T4QP2 received FDA 510(k) clearance on 2023-03-28, under 510(k) number K222729.

Who is the listed applicant for Electrical Scooter, WT-T4QP2?

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 Electrical Scooter, WT-T4QP2?

The FDA product code for Electrical Scooter, WT-T4QP2 is INI.

其他以 Wu’S Tech Co., Ltd. 為申請人之記錄

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。

K192308吳氏電動滑板車 K181163吳氏電動輪椅

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。

K261078電動滑板車（FNS01,FNS03）Anhui Jbh Medical Apparatus Co., Ltd.K261859電動滑板車（FDB08、FDB08A、FDB12）Anhui JBH Medical Apparatus Co., Ltd.K260176行動輪椅（W3483、W3483A）Zhejiang Innuovo Rehabilitation Devices Co.,Ltd K260094行動輪椅（W3465，W3902（S50碳鋼））Zhejiang Innuovo Rehabilitation Devices Co.,Ltd K261232IERO行動輪椅（IERO-01）Jochu Technology Co., Ltd.K261163行動輪椅（R200）Yongkang Ruihe Metal Product Co., Ltd.

官方來源

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