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    K Number
    K070474
    Device Name
    NEWLIFE SCIENCES LLC, MODEL TMR
    Manufacturer
    NEWLIFE SCIENCES, LLC
    Date Cleared
    2007-04-25

    (64 days)

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

    NEWLIFE SCIENCES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NewLife Sciences LLC, Model TMR, is intended for temporary symptomatic relief of chronic intractable pain, and as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
    Device Description
    The NewLife Sciences LLC, Model TMR, consists of a control console, two Treatment Probes (electrodes), and a Security Cartridge. The system operates on 115V wall current. Treatment, intended to take place under the supervision of a physician in a medical setting, consists of applying very low current to painful tissue and associated trigger points with the Treatment Probes.
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