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)

Rowheels 革命 1.0

K 號：K190699 · 2019-05-09

申請人Rowheels, Inc.
決定日期2019-05-09
產品代碼IOR
諮詢委員會PM
決定相當於

器材摘要

Rowheels Revolution 1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Rowheels, Inc.. It received FDA 510(k) clearance on 2019-05-09 under 510(k) number K190699. 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 Rowheels Revolution 1.0?

Rowheels Revolution 1.0 is a medical device that received FDA 510(k) clearance on 2019-05-09. The listed applicant is Rowheels, Inc.. The 510(k) number is K190699.

When did Rowheels Revolution 1.0 receive FDA 510(k) clearance?

Rowheels Revolution 1.0 received FDA 510(k) clearance on 2019-05-09, under 510(k) number K190699.

Who is the listed applicant for Rowheels Revolution 1.0?

The FDA 510(k) record lists Rowheels, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rowheels Revolution 1.0?

The FDA product code for Rowheels Revolution 1.0 is IOR.

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：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。

K253762ErgoSteel (ES0001/696)Strongback Mobility AG C/O Blueaudit GmbHK261919多功能輪椅（YJ-059）Zhenjiang Assure Medical Equipment Co., Ltd.K260144傾斜輪椅（YJ-013L）Zhenjiang Assure Medical Equipment Co., Ltd.K260141體重減輕重型輪椅 (YJ-010V, YJ-010C)Zhenjiang Assure Medical Equipment Co., Ltd.K260145YJ-K1K2 轮椅 (YJ-013F)Zhenjiang Assure Medical Equipment Co., Ltd.K261571手動輪椅（H008，PCK7）Jiangsu Yuyue Medical Equipment & Supply 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。

↑