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510(k) Data Aggregation

    K Number
    K100668
    Device Name
    NEMA-ST, MODEL V1.0.2
    Manufacturer
    NERVOMATRIX LTD
    Date Cleared
    2010-12-08

    (274 days)

    Product Code
    GZJCFR
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    NERVOMATRIX LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    NeMa-st is intended for Transcutaneous Electrical Nerve Stimulation (TENS) for back pain relief. NeMa-st is indicated for the relief and management of symptomatic chronic or intractable back pain and/or post-surgical back pain and/or post trauma back pain.
    Device Description
    The NeMa-st is a pain relief treatment console, which includes Screen, Mouse, Kevboard, Processor, embedded Software, Power Supplies and the stimulator circuitry and probes.
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