免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

Quingo Classic 電動輪椅 S1301，Quingo Flyte 電動輪椅 S551，Quingo Toura 電動輪椅 5350

K 號：K170634 · 2017-11-29

申請人Advanced Vehicle Concepts , Ltd.
決定日期2017-11-29
產品代碼INI
諮詢委員會PM
決定相當於

器材摘要

Quingo Classic Power Scooter S1301, Quingo Flyte Power Scooter S551, Quingo Toura Power Scooter 5350 is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Vehicle Concepts , Ltd.. It received FDA 510(k) clearance on 2017-11-29 under 510(k) number K170634. 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 Quingo Classic Power Scooter S1301, Quingo Flyte Power Scooter S551, Quingo Toura Power Scooter 5350?

Quingo Classic Power Scooter S1301, Quingo Flyte Power Scooter S551, Quingo Toura Power Scooter 5350 is a medical device that received FDA 510(k) clearance on 2017-11-29. The listed applicant is Advanced Vehicle Concepts , Ltd.. The 510(k) number is K170634.

When did Quingo Classic Power Scooter S1301, Quingo Flyte Power Scooter S551, Quingo Toura Power Scooter 5350 receive FDA 510(k) clearance?

Quingo Classic Power Scooter S1301, Quingo Flyte Power Scooter S551, Quingo Toura Power Scooter 5350 received FDA 510(k) clearance on 2017-11-29, under 510(k) number K170634.

Who is the listed applicant for Quingo Classic Power Scooter S1301, Quingo Flyte Power Scooter S551, Quingo Toura Power Scooter 5350?

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

What is the FDA product code for Quingo Classic Power Scooter S1301, Quingo Flyte Power Scooter S551, Quingo Toura Power Scooter 5350?

The FDA product code for Quingo Classic Power Scooter S1301, Quingo Flyte Power Scooter S551, Quingo Toura Power Scooter 5350 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.

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。

↑