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510(k) Data Aggregation

    K Number
    K111279
    Device Name
    NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM
    Manufacturer
    ZYNEX MEDICAL, INC.
    Date Cleared
    2011-09-20

    (138 days)

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

    NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM

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

    Interferential Mode (IFC)

    • . Symptomatic relief of chronic intractable pain, post-traumatic and postsurgical pain.
      Neuromuscular Electrical Stimulation Mode (NMES)
    • . Muscle Re-education
    • . Prevention or Retardation of Disuse Atrophy
    • . Increasing Local Blood Circulation
    • . Maintaining or Increasing Range of Motion
    • . Relaxation of Muscle Spasms
      Transcutaneous Electrical Nerve Stimulation Mode (TENS)
    • . Management and Symptomatic Relief of Chronic Intractable Pain, Posttraumatic and Post-surgical Pain.
    Device Description

    Combination Neuromuscular Electrical Stimulator, Interferential Stimulator, and Transcutaneous Electrical Nerve Stimulator, Model NexWave.

    AI/ML Overview

    I am sorry, but the provided text from the FDA 510(k) letter for the Zynex Medical Combination Neuromuscular Electrical Stimulator, Interferential Stimulator, and Transcutaneous Electrical Nerve Stimulator, Model NexWave (K111279) does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

    The document is a letter from the FDA to Zynex Medical, informing them that their device has been found substantially equivalent to legally marketed predicate devices. It outlines the regulatory classification, general controls provisions, and refers to the indications for use.

    Crucially, it does not describe any specific performance study, clinical trial data, or detailed technical specifications related to the device's accuracy, efficacy metrics, or statistical results that would allow me to populate the requested table and answer the study-related questions. The letter focuses on the regulatory determination of substantial equivalence, not on a detailed performance evaluation report.

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

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