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510(k) Data Aggregation

    K Number
    K241862
    Device Name
    Levina Pelvic Floor Muscle Stimulator (RS-48)
    Manufacturer
    ZMI Electronics Ltd.
    Date Cleared
    2025-03-27

    (273 days)

    Product Code
    KPI
    Regulation Number
    876.5320
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZMI Electronics Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.
    Device Description
    Levina Pelvic Floor Muscle Stimulator is a non-implantable, home use device for the treatments of stress, urge, and mixed urine incontinence through the intravaginal probe's electrical stimuli to the muscles of the pelvic floor to induce Kegel-like contractions, which help users to achieve pelvic floor muscle strengthening for maintaining urinary continence in women. The subject device includes a remote control, a stimulator pod and a vagina stimulation probe. Both the remote control and the stimulator pod are powered by an off-the-shelf 3.7V lithium-ion polymer battery. The remote control has a 1.77" TFT LCD screen and 4 buttons to control the stimulator pod. The stimulator pod has two output channels and will perform electrical stimulation according to the parameter settings sent by the remote control. The device is supplied with a reusable (single-patient use) vaginal, dual-electrode, stimulation probe.
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    K Number
    K231166
    Device Name
    Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes
    Manufacturer
    ZMI Electronics Ltd.
    Date Cleared
    2024-01-18

    (268 days)

    Product Code
    KPI, HIR
    Regulation Number
    876.5320
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZMI Electronics Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Levina Incontinence Stimulation Electrodes are intended to provide electromyography feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.
    Device Description
    Levina Incontinence Stimulation Electrodes are used to treat incontinence when paired with compatible, FDA-cleared electrical stimulators. The probes are intended to provide electrical stimulation to pelvic musculature and for the purpose of rehabilitation of pelvic floor muscles and restoration of neuromuscular control during treatment. The probes come in different models and are available for both vaginal and rectal insertion. The probes are used directly by the patients for home care and are for single-patient, repeat-use. The device comes non-sterile and should be cleaned before and after each use with water and mild soap or neutral detergent.
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