FDA 510(k)Lympha-Flow(LF1200)
K 號:K160178 · 2017-01-11
決定日期2017-01-11
產品代碼IRP
諮詢委員會PM
決定相當於
器材摘要
Lympha-Flow(LF1200) is the device name listed in this FDA 510(k) record. The listed applicant is Daesung Maref Co., Ltd.. It received FDA 510(k) clearance on 2017-01-11 under 510(k) number K160178. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Lympha-Flow(LF1200)?
Lympha-Flow(LF1200) is a medical device that received FDA 510(k) clearance on 2017-01-11. The listed applicant is Daesung Maref Co., Ltd.. The 510(k) number is K160178.
When did Lympha-Flow(LF1200) receive FDA 510(k) clearance?
Lympha-Flow(LF1200) received FDA 510(k) clearance on 2017-01-11, under 510(k) number K160178.
Who is the listed applicant for Lympha-Flow(LF1200)?
The FDA 510(k) record lists Daesung Maref Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Lympha-Flow(LF1200)?
The FDA product code for Lympha-Flow(LF1200) is IRP.
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。
其他以 Daesung Maref Co., Ltd. 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。
查看所有 10 項裝置 →
相關器械(代碼:IRP)
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。
K260944瑪娜冷壓系統Manamed, LLCK260529空壓按摩器(HY-1165)Xiamen High Top Electronic Technology Co., Ltd.K260948空壓按摩器(EP30B001 I)Wavepulse (Xiamen) Healthcare Technology Co., Ltd.K253919冷熱療法系統Xiamen Weiyou Intelligent Technology Co., Ltd.K252396冷凍運動2.0(AVA 501)Avanutri Equipamentos DE SaúdeK254200空气压缩腿部按摩器(LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1, LF-FT005-1, LF-FT006-1, LF-FT007, LF-FT008, LF-FT009, LF-FT010, LF-FT011, LF-FT012, LF-FT013, LF-FT014, LF-FT015, LF-FT016, UM-01, UM-02, UM-03, UM-03-1, UM-04-1, UM-05-1, UM-06-1, UM-07, UM-08, UM-09, UM-10, UM-11, UM-12, UM-13, UM-14, UM-15, UM-16, AI-01, AI-02, AI-03, AI-04, AI-05, AI-06, AI01, AI02, AI03, AI-07, AI-08, AI-09, AI-10, AI-11, AI-12, AI-13, AI-14)Wenzhou Lingfeng Electronic Technology Co., Ltd.