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FDA 510(k)

Levina Pelvic Floor Muscle Stimulator (RS-48)

K-Number: K241862 · 2025-03-27

ApplicantZmi Electronics , Ltd.
Decision Date2025-03-27
Product CodeKPI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Levina Pelvic Floor Muscle Stimulator (RS-48) is a medical device manufactured by Zmi Electronics , Ltd.. It received FDA 510(k) clearance on 2025-03-27 under approval number K241862. 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 Pelvic Floor Muscle Stimulator (RS-48)?

Levina Pelvic Floor Muscle Stimulator (RS-48) is a medical device that received FDA 510(k) clearance on 2025-03-27. It is manufactured by Zmi Electronics , Ltd.. The 510(k) number is K241862.

When was Levina Pelvic Floor Muscle Stimulator (RS-48) approved by the FDA?

Levina Pelvic Floor Muscle Stimulator (RS-48) received FDA 510(k) clearance on 2025-03-27, under approval number K241862.

What company makes Levina Pelvic Floor Muscle Stimulator (RS-48)?

Levina Pelvic Floor Muscle Stimulator (RS-48) is manufactured by Zmi Electronics , Ltd..

What is the FDA product code for Levina Pelvic Floor Muscle Stimulator (RS-48)?

The FDA product code for Levina Pelvic Floor Muscle Stimulator (RS-48) is KPI.

Related Clinical Trials

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 NCT07592403 Efficacy of Pulsed Electromagnetic Field Therapy on Women With Endometriosis RECRUITING NCT07574268 Efficacy of Transcutaneous Electrical Neural Stimulation and Tadalafil in Men With Erectile Dysfunction: A Randomized, Double-Blind, Bi-centric, Placebo- and Sham-Controlled Trial COMPLETED NCT06251557 Core Massage and Exercise in Pediatric LUTD COMPLETED NCT07554612 The Impact of Trunk and Lower Extremity Electrical Stimulation on Pelvic Floor Muscle Strength in Females RECRUITING

Other Devices by Zmi Electronics , Ltd.

K180865ZMI Self-Adhesive Electrodes K231166Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes

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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