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510(k) Data Aggregation

    K Number
    K023347
    Device Name
    VITAL STIM
    Manufacturer
    CHATTANOOGA GROUP
    Date Cleared
    2002-12-06

    (60 days)

    Product Code
    IPF
    Regulation Number
    890.5850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VITAL STIM

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

    Muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for the Chattanooga VitalStim, a powered muscle stimulator. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, it does not contain the detailed information about acceptance criteria and specific studies that would allow me to populate the requested table and answer the study-related questions.

    Therefore, I cannot provide the requested information based on the provided document. The document is primarily a regulatory clearance letter, not a detailed study report or clinical trial summary.

    I am unable to populate the table and answer the questions because the necessary information is not present in the provided text.

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