KPI — Stimulator, Electrical, Non-Implantable, For Incontinence Class II
FDA product code KPI covers "Stimulator, Electrical, Non-Implantable, For Incontinence", a Class II medical device regulated under 21 CFR 876.5320. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K260178 | shenzhen konmed technology co | Pelvic Muscle Trainer (KM510, KM516B) | June 18, 2026 |
| K252601 | hunan accurate bio-medical technology co | Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Tr | May 14, 2026 |
| K252552 | shenzhen changkun technology co | Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303) | May 6, 2026 |
| K252831 | dolanvy (suzhou) medical technology co | Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, | April 28, 2026 |
| K252334 | pontemedag | PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0- | April 17, 2026 |
| 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 |