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510(k) Data Aggregation

    K Number
    K013507
    Device Name
    COSMO TENS PF-990 MINI DIGITAL WIRELESS PATCH
    Manufacturer
    COSMO HEALTH INC.
    Date Cleared
    2002-01-25

    (95 days)

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

    COSMO HEALTH INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The COSMO TENS PF-990 Mini Digital Wireless Patch, a Transcutaneous Electrical Nerve Stimulator is indicated only for symptomatic relief of chronic intractable pain, post-traumatic and post-surgical pain relief. COSMO TENS PF-990 is indicated to be well attached to the skin by its patch before being turned on. It provides low frequency therapy that makes use of weak electrical currents applied to the body to directly stimulate nerve pathways.
    Device Description
    Not Found
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