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510(k) Data Aggregation

    K Number
    K032003
    Device Name
    PREMIER PLUS
    Manufacturer
    AMERICAN IMEX
    Date Cleared
    2004-01-07

    (194 days)

    Product Code
    GZJ
    Regulation Number
    882.5890
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    K061516
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Transcutaneous Electrical Nerve Stimulation devices are used for the symptomatic relief and management of chronic intractable pain and for the symptomatic relief of acute post traumatic pain problems.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a Transcutaneous Electrical Nerve Stimulator (TENS) device called "American Imex Premier Plus." It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

    The letter states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices for the indications for use stated in the enclosure (which is "symptomatic relief and management of chronic intractable pain and as an adjunctive treatment in the management of post surgical and post traumatic acute pain problems").

    Since the document is a regulatory clearance letter and not a study report, it inherently cannot answer your specific questions related to acceptance criteria and study details.

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