FDA 510(k)

eFOLDi 車輪椅，輕型

K 號：K223492 · 2023-02-22

決定日期2023-02-22

產品代碼INI

諮詢委員會PM

決定相當於

器材摘要

eFOLDi Scooter, Lite is the device name listed in this FDA 510(k) record. The listed applicant is Suntech UK , Ltd.. It received FDA 510(k) clearance on 2023-02-22 under 510(k) number K223492. 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 eFOLDi Scooter, Lite?

eFOLDi Scooter, Lite is a medical device that received FDA 510(k) clearance on 2023-02-22. The listed applicant is Suntech UK , Ltd.. The 510(k) number is K223492.

When did eFOLDi Scooter, Lite receive FDA 510(k) clearance?

eFOLDi Scooter, Lite received FDA 510(k) clearance on 2023-02-22, under 510(k) number K223492.

Who is the listed applicant for eFOLDi Scooter, Lite?

The FDA 510(k) record lists Suntech UK , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for eFOLDi Scooter, Lite?

The FDA product code for eFOLDi Scooter, Lite is INI.

其他以 Suntech UK , 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。

K243110eFOLDi導航電動輪椅 (STPC-A)

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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