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    K Number
    K041575
    Device Name
    FENZIAN TREATMENT SYSTEM
    Manufacturer
    EUMEDIC LIMITED
    Date Cleared
    2004-07-16

    (32 days)

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

    EUMEDIC LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TENS applications: - Symptomatic relief and management of chronic, intractable pain . - Adjunctive treatment for post-surgical and post-trauma acute pain .
    Device Description
    The Fenzian Treatment System is an electrical device designed for use as a Transcutaneous Electrical Nerve Stimulator (TENS) which operates by delivering an electrical current through the skin to the cutaneous (surface) and afferent (deep) nerves to control pain. The complete system is comprised of the stimulator and battery.
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