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510(k) Data Aggregation

    K Number
    K032988
    Device Name
    ELPHA 4 CONTI
    Manufacturer
    DANMETER A/S
    Date Cleared
    2003-12-03

    (70 days)

    Product Code
    KPI
    Regulation Number
    876.5320
    Type
    Abbreviated
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ELPHA 4 CONTI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Electrical stimulation of the pelvic floor muscles with the use of vaginal probe. The effect is strengthening the pelvic floor muscles and an activation of the central nervous system.

    Electrical stimulation of the pelvic floor muscles can reduce urinary incontinence among stress and urge incontinent adult females.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called ELPHA 4 Conti, a non-implanted electrical continence device. It does not contain the specific information required to answer the prompt regarding acceptance criteria and the study that proves the device meets those criteria.

    Therefore, I cannot provide the requested information based on the given text.

    The document does not describe:

    • Any acceptance criteria.
    • Any specific study performed to prove device performance.
    • Sample sizes, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details.

    The letter merely states that the FDA has reviewed the 510(k) premarket notification and determined the device is substantially equivalent to legally marketed predicate devices for the indicated uses.

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