FDA 510(k)

行動輪椅（型號：W3431Q、W3431R）

K 號：K222507 · 2023-02-28

申請人Zhejiang Innuovo Rehabilitation Devices Co.,Ltd

決定日期2023-02-28

產品代碼INI

諮詢委員會PM

決定相當於

器材摘要

Mobility Scooter (Models: W3431Q, W3431R) 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 2023-02-28 under 510(k) number K222507. 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 (Models: W3431Q, W3431R)?

Mobility Scooter (Models: W3431Q, W3431R) is a medical device that received FDA 510(k) clearance on 2023-02-28. The listed applicant is Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. The 510(k) number is K222507.

When did Mobility Scooter (Models: W3431Q, W3431R) receive FDA 510(k) clearance?

Mobility Scooter (Models: W3431Q, W3431R) received FDA 510(k) clearance on 2023-02-28, under 510(k) number K222507.

Who is the listed applicant for Mobility Scooter (Models: W3431Q, W3431R)?

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 (Models: W3431Q, W3431R)?

The FDA product code for Mobility Scooter (Models: W3431Q, W3431R) 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。

K260094行動輪椅（W3465，W3902（S50碳鋼））K260176行動輪椅（W3483、W3483A）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.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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