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510(k) Data Aggregation

    K Number
    K253285

    Validate with FDA (Live)

    Device Name
    Elitone for Men
    Manufacturer
    Elidah, Inc.
    Date Cleared
    2026-01-23

    (116 days)

    Product Code
    QAJ
    Regulation Number
    876.5330
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Age Range
    All
    Reference & Predicate Devices
    K183585
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Elitone for Men is a non-implanted muscle stimulator designed to aid early continence recovery in men immediately following prostate surgery.

    Device Description

    The Elitone for Men device is an electrical muscle stimulator designed to speed continence recovery in men following prostate surgery. Stimulation is delivered to the pelvic floor muscles and surrounding structures via a disposable electrode component configured to be applied to the skin in the perineal region. A small control unit component generates a therapeutic stimulation and allows the patient to increment or decrement the stimulation intensity. The applied electrical stimulation causes muscle contraction and relaxation in a treatment regimen that, with regular use over multiple weeks, is intended to speed continence recovery.

    AI/ML Overview

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