Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Zmi Electronics , Ltd.. It received FDA 510(k) clearance on 2024-01-18 under 510(k) 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. The listed applicant is Zmi Electronics , Ltd.. The 510(k) number is K231166.

When did Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes receive FDA 510(k) clearance?

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

Who is the listed applicant for Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes?

The FDA 510(k) record lists Zmi Electronics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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.

NCT07534696Evaluation of Non-Invasive Pelvic Floor Neuromuscular Stimulation for Urinary Incontinence After ProstatectomyENROLLING_BY_INVITATIONNCT07698028ExMI vs. Biofeedback PFMT for Post-Prostatectomy IncontinenceACTIVE_NOT_RECRUITINGNCT07742176Transcutaneous Tibial Nerve Stimulation for Urinary Incontinence After Radical ProstatectomyNOT_YET_RECRUITINGNCT07792031Comparing the Effect of Two Types of Pelvic Floor Muscle Stimulation Devices to Improve Symptoms of Urinary Incontinence in Women.NOT_YET_RECRUITINGNCT06532292Physical Therapy Intervention for Pelvic Organ ProlapsesCOMPLETEDNCT07070063Virtual Reality for Urinary Incontinence in WomenCOMPLETED

Other records listing Zmi Electronics , 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.

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

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.

K260178Pelvic Muscle Trainer (KM510, KM516B)Shenzhen Konmed Technology Co., Ltd.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.

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.

↑