電動輪椅（OS-R-M01S）
K 號：K253952 · 2026-04-07
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器材摘要
Power Wheelchair (OS-R-M01S) is the device name listed in this FDA 510(k) record. The listed applicant is Beijing OrionStar Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-04-07 under 510(k) number K253952. 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 (OS-R-M01S)?
Power Wheelchair (OS-R-M01S) is a medical device that received FDA 510(k) clearance on 2026-04-07. The listed applicant is Beijing OrionStar Technology Co., Ltd.. The 510(k) number is K253952.
When did Power Wheelchair (OS-R-M01S) receive FDA 510(k) clearance?
Power Wheelchair (OS-R-M01S) received FDA 510(k) clearance on 2026-04-07, under 510(k) number K253952.
Who is the listed applicant for Power Wheelchair (OS-R-M01S)?
FDA 510(k) 記錄將北京奧里恩星科技有限公司列為申請人。這並不單獨確立設備製造商。
What is the FDA product code for Power Wheelchair (OS-R-M01S)?
The FDA product code for Power Wheelchair (OS-R-M01S) is ITI.
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。
其他以 Beijing OrionStar Technology 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。
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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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