Pelvic Muscle Trainer (KM510, KM516B)— 510(k) K260178
Substantially EquivalentShenzhen Konmed Technology Co., Ltd.
FDA 510(k) clearance K260178 for Pelvic Muscle Trainer (KM510, KM516B), Substantially Equivalent on 2026-06-18. Applicant: Shenzhen Konmed Technology Co., Ltd.. Device class: 2.
Summary
Shenzhen Konmed Technology's Pelvic Muscle Trainer comes in two models, KM510 and KM516B. It's filed under KPI, non-implantable electrical stimulators for incontinence, and the record doesn't say how the models differ.
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).
Konmed filed from Shenzhen, China. The decision came 148 calendar days after FDA received it (January 21 to June 18, 2026).
Clearance details
- Applicant
- Shenzhen Konmed Technology Co., Ltd.
- 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
- Shenzhen, CN
Recent devices under product code KPI
view all- K262353 — BTL-299-F
- 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)
- K252334 — PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)
More clearances from Shenzhen Konmed Technology Co., Ltd.
view all- K233576 — Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013 +1 more
- K220161 — Biofeedback Nerve and Muscle Stimulator
- K202648 — Biofeedback Nerve and Muscle Stimulator
- K163288 — Pelvifine Pelvic Muscle Trainer
- K171722 — Electrodes with snap / Electrodes with pigtail
Data sourced from openFDA. This site is unofficial and independent of the FDA.