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FDA 510(k)

驅動輪椅

K 號：K212854 · 2022-01-10

申請人Zhejiang Qianxi Vehicle Co., Ltd.
決定日期2022-01-10
產品代碼ITI
諮詢委員會PM
決定相當於

器材摘要

Powered Wheelchair is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Qianxi Vehicle Co., Ltd.. It received FDA 510(k) clearance on 2022-01-10 under 510(k) number K212854. 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 Powered Wheelchair?

Powered Wheelchair is a medical device that received FDA 510(k) clearance on 2022-01-10. The listed applicant is Zhejiang Qianxi Vehicle Co., Ltd.. The 510(k) number is K212854.

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

Powered Wheelchair received FDA 510(k) clearance on 2022-01-10, under 510(k) number K212854.

Who is the listed applicant for Powered Wheelchair?

The FDA 510(k) record lists Zhejiang Qianxi Vehicle Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powered Wheelchair?

The FDA product code for Powered Wheelchair is ITI.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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。

K262582電動輪椅（GP100）Suzhou Green Pine Medical Co., Ltd.K262054電動輪椅Yongkang Joymax Medical Technology Co., Ltd.K260053電動輪椅 (OS-R-M01I)Beijing OrionStar Technology Co., Ltd.K260229電動輪椅（HC819N、HC830N、HC831N）Yongkang Hengyi Vehicle Co., Ltd.K261354電動輪椅（D03）Foshan Sowell Medical Technology Co., Ltd.K261149電動輪椅（DY611A-2，DY612A-1）Zhejiang Lumbre Electric Appliance Co., Ltd.

官方來源

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