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FDA 510(k)

Pelvic Muscle Trainer (KM510, KM516B)

K-Number: K260178 · 2026-06-18

ApplicantShenzhen Konmed Technology Co., Ltd.
Decision Date2026-06-18
Product CodeKPI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Pelvic Muscle Trainer (KM510, KM516B) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Konmed Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-06-18 under 510(k) number K260178. The device is classified under product code KPI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pelvic Muscle Trainer (KM510, KM516B)?

Pelvic Muscle Trainer (KM510, KM516B) is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is Shenzhen Konmed Technology Co., Ltd.. The 510(k) number is K260178.

When did Pelvic Muscle Trainer (KM510, KM516B) receive FDA 510(k) clearance?

Pelvic Muscle Trainer (KM510, KM516B) received FDA 510(k) clearance on 2026-06-18, under 510(k) number K260178.

Who is the listed applicant for Pelvic Muscle Trainer (KM510, KM516B)?

The FDA 510(k) record lists Shenzhen Konmed Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pelvic Muscle Trainer (KM510, KM516B)?

The FDA product code for Pelvic Muscle Trainer (KM510, KM516B) is KPI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07687173Assessment of Effectiveness of Pelvic Floor Muscle Training With Biofeedback in Male With Hypogonadism and Erectile DysfunctionNOT_YET_RECRUITING

Other records listing Shenzhen Konmed Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233576Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018)K220161Biofeedback Nerve and Muscle StimulatorK202648Biofeedback Nerve and Muscle StimulatorK163288Pelvifine Pelvic Muscle TrainerK171722Electrodes with snap / Electrodes with pigtailK171721Electrodes with silver conductive

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Related Devices (Code: KPI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252601Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L)Hunan Accurate Bio-Medical Technology Co., Ltd.K252552Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)Shenzhen Changkun Technology Co., Ltd.K252831Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)Dolanvy (Suzhou) Medical Technology Co., Ltd.K252334PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)PontemedagK251760Well-Life Incontinence Stimulation System (WL-2405i(P))Well-Life Healthcare , Ltd.K251026Regenesis EMS ChairTrinity Medical Solutions

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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