KPI
- 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)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K260178 | 2026-06-18 | Shenzhen Konmed Technology Co., Ltd. | Pelvic Muscle Trainer (KM510, KM516B) | |
| K252601 | 2026-05-14 | Hunan Accurate Bio-Medical Technology … | Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer… | |
| K252552 | 2026-05-06 | Shenzhen Changkun Technology Co., Ltd. | Pelvic Floor Rehabilitation Therapy Device (PD2301/P… | |
| K252831 | 2026-04-28 | Dolanvy (Suzhou) Medical Technology Co… | Pelvic Floor Treatment Device (DLR-8920, DLR-8921, D… | — |
| K252334 | 2026-04-17 | Pontemedag | PELVIPOWER Pelvic Functional Magnetic Stimulation (P… | |
| K251760 | 2026-02-12 | Well-Life Healthcare , Ltd. | Well-Life Incontinence Stimulation System (WL-2405i(… | |
| K251026 | 2025-08-29 | Trinity Medical Solutions | Regenesis EMS Chair | |
| K243079 | 2025-06-26 | Verity Medical , Ltd. | NeuroTrac® MyoPlus Pro (MYO120U) | |
| K241862 | 2025-03-27 | Zmi Electronics , Ltd. | Levina Pelvic Floor Muscle Stimulator (RS-48) | |
| K241516 | 2025-02-10 | BTL Industries, Inc. | BTL-398 | |
| K241899 | 2024-11-27 | Easymed Instruments Co., Ltd. | Pelvic Floor Stimulator (Intrelief PFE) | — |
| K234061 | 2024-07-01 | Fotona D.O.O. | StarFormer | |
| K233576 | 2024-02-23 | Shenzhen Konmed Technology Co., Ltd. | Konmed Incontinence Stimulation Electrode (Vaginal P… | — |
| K231166 | 2024-01-18 | Zmi Electronics , Ltd. | Levina, Levina Incontinence Stimulation Electrodes (… | |
| K230983 | 2023-10-20 | Tenscare, Ltd. | Unicare (K-UNICARE-USA) | |
| K230780 | 2023-10-05 | Zimmer Medizinsysteme GmbH | MFG-05 | |
| K230767 | 2023-09-21 | Nanjing Vishee Medical Technology Co.,… | Pelvic Floor Muscle Stimulator |
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。