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FDA 510(k)

Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018)

K-Number: K233576 · 2024-02-23

ApplicantShenzhen Konmed Technology Co., Ltd.
Decision Date2024-02-23
Product CodeKPI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018) is a medical device manufactured by Shenzhen Konmed Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-02-23 under approval number K233576. 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 Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018)?

Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018) is a medical device that received FDA 510(k) clearance on 2024-02-23. It is manufactured by Shenzhen Konmed Technology Co., Ltd.. The 510(k) number is K233576.

When was Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018) approved by the FDA?

Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018) received FDA 510(k) clearance on 2024-02-23, under approval number K233576.

What company makes Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018)?

Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018) is manufactured by Shenzhen Konmed Technology Co., Ltd..

What is the FDA product code for Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018)?

The FDA product code for Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018) is KPI.

Related Clinical Trials

NCT07604415 Active Versus Passive Anal Sphincter Training in Patients With Fecal Incontinence RECRUITING NCT07534696 Evaluation of Non-Invasive Pelvic Floor Neuromuscular Stimulation for Urinary Incontinence After Prostatectomy ENROLLING_BY_INVITATION NCT07187388 Investigating the Impact of Electrical Stimulation on Facial Pain, Jaw Movement and Oral Health in People With Motor Neuron Disease. RECRUITING NCT02911103 Deep Brain Stimulation Surgery for Focal Hand Dystonia ACTIVE_NOT_RECRUITING NCT07602933 Photobiomodulation Effects on Fatigue and Muscle Damage Induced by NMES NOT_YET_RECRUITING NCT06275282 Regenerative Peripheral Nerve Interface for Control of Lower Limb Prostheses RECRUITING

Other Devices by Shenzhen Konmed Technology Co., Ltd.

K163288Pelvifine Pelvic Muscle Trainer K171722Electrodes with snap / Electrodes with pigtail K171721Electrodes with silver conductive K202648Biofeedback Nerve and Muscle Stimulator K220161Biofeedback Nerve and Muscle Stimulator

Related Devices (Code: KPI)

K162010HPM-6000UBTL Industries, Inc. K161055Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15Fuji Dynamics , Ltd. K160773Yarlap IIInternational Trade Group, Inc. K161349Everyway Incontinence Stimulation SystemEveryway Medical Instrument Co., Ltd. K181497HPM-6000UFBTL Industries, Inc. K171430Incontinence Treatment Device, Model LT2061Shenzhen Dongdixin Technology Co., Ltd.

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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