KPI — Stimulator, Electrical, Non-Implantable, For Incontinence Class II
FDA Device Classification
Classification Details
- Product Code
- KPI
- Device Class
- Class II
- Regulation Number
- 876.5320
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K251760 | well-life healthcare | Well-Life Incontinence Stimulation System (WL-2405i(P)) | February 12, 2026 |
| K251026 | trinity medical solutions | Regenesis EMS Chair | August 29, 2025 |
| K243079 | verity medical | NeuroTrac® MyoPlus Pro (MYO120U) | June 26, 2025 |
| K241862 | zmi electronics | Levina Pelvic Floor Muscle Stimulator (RS-48) | March 27, 2025 |
| K241516 | btl industries | BTL-398 | February 10, 2025 |
| K241899 | easymed instruments co | Pelvic Floor Stimulator (Intrelief PFE) | November 27, 2024 |
| K234061 | fotona | StarFormer | July 1, 2024 |
| K233576 | shenzhen konmed technology co | Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505 | February 23, 2024 |
| K231166 | zmi electronics | Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscl | January 18, 2024 |
| K230983 | tenscare | Unicare (K-UNICARE-USA) | October 20, 2023 |
| K230780 | zimmer medizinsysteme | MFG-05 | October 5, 2023 |
| K230767 | nanjing vishee medical technology co | Pelvic Floor Muscle Stimulator | September 21, 2023 |
| K222528 | well-life healthcare limited | Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incon | December 29, 2022 |
| K220161 | shenzhen konmed technology co | Biofeedback Nerve and Muscle Stimulator | July 20, 2022 |
| K213133 | oriental inspiration limited | Keffort (MC-100, MC-100A) | April 13, 2022 |
| K213116 | everyway medical instruments co | Everyway Incontinence Stimulation System | December 3, 2021 |
| K210441 | shenzhen med-link electronics tech co | Incontinence Probe | September 17, 2021 |
| K201014 | thought technology | MyOnyx System | January 13, 2021 |
| K200293 | inmode | InMode System with vTone Applicator | May 5, 2020 |
| K191312 | tenscare | Perfect PFE | November 1, 2019 |