FDA 510(k)

電動輪椅（N5515B）

K 號：K220747 · 2022-05-12

申請人Zhejiang Innuovo Rehabilitation Devices Co.,Ltd

決定日期2022-05-12

產品代碼ITI

諮詢委員會PM

決定相當於

器材摘要

Power Wheelchair (N5515B) is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. It received FDA 510(k) clearance on 2022-05-12 under 510(k) number K220747. 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 Power Wheelchair (N5515B)?

Power Wheelchair (N5515B) is a medical device that received FDA 510(k) clearance on 2022-05-12. The listed applicant is Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. The 510(k) number is K220747.

When did Power Wheelchair (N5515B) receive FDA 510(k) clearance?

Power Wheelchair (N5515B) received FDA 510(k) clearance on 2022-05-12, under 510(k) number K220747.

Who is the listed applicant for Power Wheelchair (N5515B)?

FDA 510(k) 記錄將浙江英努歐康復設備有限公司列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Power Wheelchair (N5515B)?

The FDA product code for Power Wheelchair (N5515B) is ITI.

其他以 Zhejiang Innuovo Rehabilitation Devices 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。

K260176行動輪椅（W3483、W3483A）K260094行動輪椅（W3465，W3902（S50碳鋼））K253812電動輪椅（W5915B、W5915C、W5915D）K260056電動輪椅（N5515A、N5516、N5517A、N5519）K253806電動輪椅（N5919系列）K242471Power Wheelchair (W5538)

查看所有 20 項裝置 →

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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