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510(k) Data Aggregation

    K Number
    K020032
    Device Name
    APEX MEDICAL MINI TENS
    Manufacturer
    APEX MEDICAL CORP.
    Date Cleared
    2002-01-31

    (27 days)

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

    Mini TENS is intended to be used in symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, study details (sample size, data provenance, ground truth, experts, adjudication), or comparative effectiveness studies. The document is a 510(k) clearance letter for the Apex Medical Mini TENS device, indicating its substantial equivalence to a predicate device for symptomatic relief of chronic intractable pain, post-traumatic, and post-surgical pain. It does not contain the kind of detailed study results or performance metrics you are asking for.

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