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.
Clearance details
- Applicant
- Shenzhen Konmed Technology Co., Ltd.
- Product code
- 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- 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)
- K251760 — Well-Life Incontinence Stimulation System (WL-2405i(P))
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.