FDA 510(k)

移動輪椅

K 號：K220206 · 2022-03-24

申請人Zhejiang Innuovo Rehabilitation Devices Co.,Ltd

決定日期2022-03-24

產品代碼INI

諮詢委員會PM

決定相當於

器材摘要

Mobility Scooter 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 2022-03-24 under 510(k) number K220206. 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 Mobility Scooter?

Mobility Scooter is a medical device that received FDA 510(k) clearance on 2022-03-24. The listed applicant is Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. The 510(k) number is K220206.

When did Mobility Scooter receive FDA 510(k) clearance?

Mobility Scooter received FDA 510(k) clearance on 2022-03-24, under 510(k) number K220206.

Who is the listed applicant for Mobility Scooter?

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 Mobility Scooter?

The FDA product code for Mobility Scooter is INI.

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)

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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。

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.K260094行動輪椅（W3465，W3902（S50碳鋼））Zhejiang Innuovo Rehabilitation Devices Co.,Ltd K260176行動輪椅（W3483、W3483A）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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