KPI
- Product code
- KPI
- Device name
- Stimulator, Electrical, Non-Implantable, For Incontinence
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.5320
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 17
- Summaries archived here
- 14 (direct download)
- 510(k) clearances (all years, FDA)
- 96 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (17)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| 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 |
Official FDA classification page: KPI
Classification and pathway per current FDA publications. Data from openFDA (CC0).