RoughRider Aurora 電動輪椅手冊
K 號：K200715 · 2022-06-24
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器材摘要
RoughRider Aurora Manual Wheelchair is the device name listed in this FDA 510(k) record. The listed applicant is Roughrider America, LLC. It received FDA 510(k) clearance on 2022-06-24 under 510(k) number K200715. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the RoughRider Aurora Manual Wheelchair?
RoughRider Aurora Manual Wheelchair is a medical device that received FDA 510(k) clearance on 2022-06-24. The listed applicant is Roughrider America, LLC. The 510(k) number is K200715.
When did RoughRider Aurora Manual Wheelchair receive FDA 510(k) clearance?
RoughRider Aurora Manual Wheelchair received FDA 510(k) clearance on 2022-06-24, under 510(k) number K200715.
Who is the listed applicant for RoughRider Aurora Manual Wheelchair?
The FDA 510(k) record lists Roughrider America, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for RoughRider Aurora Manual Wheelchair?
The FDA product code for RoughRider Aurora Manual Wheelchair is IOR.
相關臨床試驗
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相關器械（代碼：IOR）
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。
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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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