PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)— 510(k) K252334
Substantially EquivalentPontemedag
FDA 510(k) clearance K252334 for PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02), Substantially Equivalent on 2026-04-17. Applicant: Pontemedag. Device class: 2.
Summary
Pontemedag's PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) is filed under product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence). The name also carries the number 033-0-1100-02.
Class II, 21 CFR 876.5320. Gastroenterology and Urology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Pontemedag filed from Arbon, Switzerland. The decision came 263 calendar days after FDA received it (July 28, 2025 to April 17, 2026).
Clearance details
- Applicant
- Pontemedag
- Product code
- Product code KPI
- Device class
- Class 2
- Regulation
- 21 CFR 876.5320
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Arbon, CH
Recent devices under product code KPI
view all- K262353 — BTL-299-F
- K260178 — Pelvic Muscle Trainer (KM510, KM516B)
- K252601 — Pelvic Muscle Trainer (4 models)
- K252552 — Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)
- K252831 — Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)
Data sourced from openFDA. This site is unofficial and independent of the FDA.