KPI

Stimulator, Electrical, Non-Implantable, For Incontinence

产品代码
KPI
器械名称
Stimulator, Electrical, Non-Implantable, For Incontinence
管理类别
第 2 类(Class II)
21 CFR 条款
21 CFR 876.5320
FDA 专业组
Gastroenterology, Urology
上市路径
需提交 510(k) 上市前通告
标记
可走第三方审查
该代码近三年的 510(k)
17 件
其中 Summary 已存档
14 份,可直接下载
FDA 历史累计 510(k)
96 件(全部年份;本站只收录近三年的明细)

该代码近三年的 510(k)(17 件)

数据窗口为最近三年。最新一件:2026-06-18。

510(k) 号批准日期申请人器械名称摘要
K2601782026-06-18Shenzhen Konmed Technology Co., Ltd.Pelvic Muscle Trainer (KM510, KM516B)PDF
K2526012026-05-14Hunan Accurate Bio-Medical Technology …Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer…PDF
K2525522026-05-06Shenzhen Changkun Technology Co., Ltd.Pelvic Floor Rehabilitation Therapy Device (PD2301/P…PDF
K2528312026-04-28Dolanvy (Suzhou) Medical Technology Co…Pelvic Floor Treatment Device (DLR-8920, DLR-8921, D…
K2523342026-04-17PontemedagPELVIPOWER Pelvic Functional Magnetic Stimulation (P…PDF
K2517602026-02-12Well-Life Healthcare , Ltd.Well-Life Incontinence Stimulation System (WL-2405i(…PDF
K2510262025-08-29Trinity Medical SolutionsRegenesis EMS ChairPDF
K2430792025-06-26Verity Medical , Ltd.NeuroTrac® MyoPlus Pro (MYO120U)PDF
K2418622025-03-27Zmi Electronics , Ltd.Levina Pelvic Floor Muscle Stimulator (RS-48)PDF
K2415162025-02-10BTL Industries, Inc.BTL-398PDF
K2418992024-11-27Easymed Instruments Co., Ltd.Pelvic Floor Stimulator (Intrelief PFE)
K2340612024-07-01Fotona D.O.O.StarFormerPDF
K2335762024-02-23Shenzhen Konmed Technology Co., Ltd.Konmed Incontinence Stimulation Electrode (Vaginal P…
K2311662024-01-18Zmi Electronics , Ltd.Levina, Levina Incontinence Stimulation Electrodes (…PDF
K2309832023-10-20Tenscare, Ltd.Unicare (K-UNICARE-USA)PDF
K2307802023-10-05Zimmer Medizinsysteme GmbHMFG-05PDF
K2307672023-09-21Nanjing Vishee Medical Technology Co.,…Pelvic Floor Muscle StimulatorPDF

其中 14 件的 Summary 已存档在本站,点 PDF 直接下载;其余给 FDA 官方链接。

FDA 官方分类页: KPI
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA(CC0 公有领域),不构成注册策略建议。