MI.BO.® 我肌強化電刺激系統（MB-1000、MB-600、MB-400）
K 號：K201257 · 2021-04-06
廣告
器材摘要
MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400) is the device name listed in this FDA 510(k) record. The listed applicant is Arrive Systems, Inc.. It received FDA 510(k) clearance on 2021-04-06 under 510(k) number K201257. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400)?
MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400) is a medical device that received FDA 510(k) clearance on 2021-04-06. The listed applicant is Arrive Systems, Inc.. The 510(k) number is K201257.
When did MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400) receive FDA 510(k) clearance?
MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400) received FDA 510(k) clearance on 2021-04-06, under 510(k) number K201257.
Who is the listed applicant for MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400)?
The FDA 510(k) record lists Arrive Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400)?
The FDA product code for MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400) is NGX.
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：NGX）
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。
K253790高強度聚焦電磁刺激器（FE60）Beijing Winkonlaser Technology LimitedK253926迪阿科爾ShenB Co., Ltd.K253636Zionic Pro Max (電動肌肉刺激器)Termosalud S.L.K253408涼頻Zimmer Medizinsysteme GmbHK252154攜帶式電刺激治療設備（LGT-2320BE、LGT-2320ME 及 LGT-2320SP）Guangzhou Longest Medical Technology Co., Ltd.K253478Motive™ 腰部肌肉刺激器 (OT01-1003)Motive Health, Inc.
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