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)

Kuschall K系列吸引式手動輪椅

K 號：K162692 · 2016-12-28

申請人Invacare Corporation
決定日期2016-12-28
產品代碼IOR
諮詢委員會PM
決定相當於

器材摘要

Kuschall K-Series Attract Manual Wheelchair is the device name listed in this FDA 510(k) record. The listed applicant is Invacare Corporation. It received FDA 510(k) clearance on 2016-12-28 under 510(k) number K162692. 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 Kuschall K-Series Attract Manual Wheelchair?

Kuschall K-Series Attract Manual Wheelchair is a medical device that received FDA 510(k) clearance on 2016-12-28. The listed applicant is Invacare Corporation. The 510(k) number is K162692.

When did Kuschall K-Series Attract Manual Wheelchair receive FDA 510(k) clearance?

Kuschall K-Series Attract Manual Wheelchair received FDA 510(k) clearance on 2016-12-28, under 510(k) number K162692.

Who is the listed applicant for Kuschall K-Series Attract Manual Wheelchair?

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

What is the FDA product code for Kuschall K-Series Attract Manual Wheelchair?

The FDA product code for Kuschall K-Series Attract Manual Wheelchair 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

其他以 Invacare Corporation 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。

K203210Invacare 銀河5NXG 氧氣濃縮機K202379Invacare AVIVA 風暴 RX 電動輪椅K200890Invacare 完美2V 氧氣濃縮機K192216Invacare AVIVA FX 電動輪椅，型號：IFX-20MPK191159單電池組濃縮器，配備可攜帶背包和肩帶，A型，POC1 USB 藍牙擴充棒，POC1 Invacare 移動醫療應用附加設備，適用於 iOS 和 Android 裝置，Invacare 銀河系移動氧濃縮器，具連接功能K182946Invacare TDX SP2-HD 配有船長座椅

查看所有 14 項裝置 →

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。

↑