RT300 功能電刺激環形腳踏車
K 號：K162470 · 2017-07-11
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器材摘要
RT300 FES cycle ergometer is the device name listed in this FDA 510(k) record. The listed applicant is Restorative Therapies, Inc.. It received FDA 510(k) clearance on 2017-07-11 under 510(k) number K162470. The device is classified under product code GZI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the RT300 FES cycle ergometer?
RT300 FES cycle ergometer is a medical device that received FDA 510(k) clearance on 2017-07-11. The listed applicant is Restorative Therapies, Inc.. The 510(k) number is K162470.
When did RT300 FES cycle ergometer receive FDA 510(k) clearance?
RT300 FES cycle ergometer received FDA 510(k) clearance on 2017-07-11, under 510(k) number K162470.
Who is the listed applicant for RT300 FES cycle ergometer?
The FDA 510(k) record lists Restorative Therapies, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for RT300 FES cycle ergometer?
The FDA product code for RT300 FES cycle ergometer is GZI.
相關臨床試驗
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其他以 Restorative Therapies, Inc. 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：GZI）
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。
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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