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510(k) Data Aggregation

    K Number
    K251760

    Validate with FDA (Live)

    Date Cleared
    2026-02-12

    (248 days)

    Product Code
    Regulation Number
    876.5320
    Age Range
    18 - 120
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Well-Life Incontinence Stimulation System (Model: WL-2405i(P)) is intended to provide neuromuscular electrical stimulation for the rehabilitation and re-education of weak pelvic floor muscles in adult women. It is indicated for the treatment of stress, urge, and mixed urinary incontinence and to help maintain urinary continence.

    Device Description

    The Well-Life Incontinence Stimulation System (Model: WL-2405i(P)) is a non-implantable, home use pelvic floor muscle stimulator designed to provide electrical stimulation to the pelvic floor muscles for treatment of stress, urge, and mixed urinary incontinence.

    The device contains the electrical stimulator unit, a vaginal probe, a carrying case, 2 lead wires, and a user manual. The Well-Life Incontinence Stimulation System (Model: WL-2405i(P)) has four modes. The treatment modes are designed to treat stress, urge, mixed urinary incontinence, and tone mode by providing targeted stimulation to the pelvic muscles with varying pulse widths, frequencies, ramp-up and ramp-down times, and hold-on and hold-off times. The device is powered by a rechargeable Li-ion battery and controlled by a button interface with adjustable intensity levels. An LCD display shows the current program and intensity level.

    The Well-Life Incontinence Stimulation System (Model: WL-2405i(P)) includes one reusable (single-patient use), dual electrode vaginal probe electrode (Model: SA-3478) packaged together with the main device.

    AI/ML Overview

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