北極熊 ERA 轉輪椅
K 號：K243111 · 2025-01-10
廣告
器材摘要
Bowhead ERA Wheelchairs is the device name listed in this FDA 510(k) record. The listed applicant is Bowhead Design Corp.. It received FDA 510(k) clearance on 2025-01-10 under 510(k) number K243111. 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 Bowhead ERA Wheelchairs?
Bowhead ERA Wheelchairs is a medical device that received FDA 510(k) clearance on 2025-01-10. The listed applicant is Bowhead Design Corp.. The 510(k) number is K243111.
When did Bowhead ERA Wheelchairs receive FDA 510(k) clearance?
Bowhead ERA Wheelchairs received FDA 510(k) clearance on 2025-01-10, under 510(k) number K243111.
Who is the listed applicant for Bowhead ERA Wheelchairs?
The FDA 510(k) record lists Bowhead Design Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Bowhead ERA Wheelchairs?
The FDA product code for Bowhead ERA Wheelchairs 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。
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。
廣告