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FDA 510(k)

行動輪椅（S-01）；行動輪椅（S-02）

K 號：K242714 · 2025-01-23

申請人Zhejiang Seedream Medical Equipment Co., Ltd.
決定日期2025-01-23
產品代碼INI
諮詢委員會PM
決定相當於

器材摘要

Mobility Scooter (S-01); Mobility Scooter (S-02) is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Seedream Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2025-01-23 under 510(k) number K242714. 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 (S-01); Mobility Scooter (S-02)?

Mobility Scooter (S-01); Mobility Scooter (S-02) is a medical device that received FDA 510(k) clearance on 2025-01-23. The listed applicant is Zhejiang Seedream Medical Equipment Co., Ltd.. The 510(k) number is K242714.

When did Mobility Scooter (S-01); Mobility Scooter (S-02) receive FDA 510(k) clearance?

Mobility Scooter (S-01); Mobility Scooter (S-02) received FDA 510(k) clearance on 2025-01-23, under 510(k) number K242714.

Who is the listed applicant for Mobility Scooter (S-01); Mobility Scooter (S-02)?

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

What is the FDA product code for Mobility Scooter (S-01); Mobility Scooter (S-02)?

The FDA product code for Mobility Scooter (S-01); Mobility Scooter (S-02) is INI.

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：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.,LtdK260094行動輪椅（W3465，W3902（S50碳鋼））Zhejiang Innuovo Rehabilitation Devices Co.,LtdK261232IERO行動輪椅（IERO-01）Jochu Technology Co., Ltd.K261163行動輪椅（R200）Yongkang Ruihe Metal Product Co., Ltd.

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