Livi 裝置
K 號：K252005 · 2026-03-20
廣告
決定日期2026-03-20
產品代碼HEB
諮詢委員會OB設備之醫療設備規範文本翻譯如下：
關於OB設備的醫療設備規範文件：
此設備已通過FDA認證，並獲得510(k)許可證。該設備的PMA申請已提交，並在NCT登錄編號為[編號]的研究中進行測試。相關文獻的PMID編號為[編號]。請參考以下識別碼和網址：
識別碼：[識別碼]
網址：[網址]
政策：醫療規範-v1
決定相當於
器材摘要
Livi Device is the device name listed in this FDA 510(k) record. The listed applicant is Liviwell, Inc.. It received FDA 510(k) clearance on 2026-03-20 under 510(k) number K252005. The device is classified under product code HEB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Livi Device?
Livi Device is a medical device that received FDA 510(k) clearance on 2026-03-20. The listed applicant is Liviwell, Inc.. The 510(k) number is K252005.
When did Livi Device receive FDA 510(k) clearance?
Livi Device received FDA 510(k) clearance on 2026-03-20, under 510(k) number K252005.
Who is the listed applicant for Livi Device?
The FDA 510(k) record lists Liviwell, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Livi Device?
The FDA product code for Livi Device is HEB.
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：HEB）
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。
K253719無香月經長型置入器衛生棉條；無香月經紙盒置入器衛生棉條；無香月經數位衛生棉條Unibeauty (Hubei) Technology Co., Ltd.K252939COHITECH 有機棉緊湊式膠囊棒針Cotton High Tech S.L.K252613無香月經三件式推入式衛生棉棒Unibeauty (Hubei) Technology Co., Ltd.K251033無香月經長型針筒式衛生棉棒；無香月經精巧針筒式衛生棉棒；無香月經紙盒針筒式衛生棉棒；無香月經數位衛生棉棒Unibeauty (Hubei) Technology Co., Ltd.K242105SABA 月經棉棒Essity Higiene Y Salud Mexico. S.A. DE C.V.K241064無香衛生棉棒Shandong Intco Hygiene Products 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