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FDA 510(k)

Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes

K-Number: K231166 · 2024-01-18

ApplicantZmi Electronics , Ltd.
Decision Date2024-01-18
Product CodeKPI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes is a medical device manufactured by Zmi Electronics , Ltd.. It received FDA 510(k) clearance on 2024-01-18 under approval number K231166. 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 Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes?

Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes is a medical device that received FDA 510(k) clearance on 2024-01-18. It is manufactured by Zmi Electronics , Ltd.. The 510(k) number is K231166.

When was Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes approved by the FDA?

Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes received FDA 510(k) clearance on 2024-01-18, under approval number K231166.

What company makes Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes?

Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes is manufactured by Zmi Electronics , Ltd..

What is the FDA product code for Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes?

The FDA product code for Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes is KPI.

Related Clinical Trials

NCT06998134 Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults RECRUITING NCT06868914 Phase I Trial of High-Density Theta Burst Stimulation (hdTBS) NOT_YET_RECRUITING NCT07615465 An Osseointegrated Transfemoral Prosthesis Offering Long-Term Bi-Directional Efferent-Afferent Neural Transmission ACTIVE_NOT_RECRUITING NCT01961557 Evaluating a New Knee-Ankle-Foot Brace to Improve Gait in Children With Movement Disorders COMPLETED NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT07615686 tSCS in Children With Spina Bifida RECRUITING

Other Devices by Zmi Electronics , Ltd.

K180865ZMI Self-Adhesive Electrodes K241862Levina Pelvic Floor Muscle Stimulator (RS-48)

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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