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510(k) Data Aggregation

    K Number
    K013167
    Device Name
    MODEL7500 MICROCURRENT TENS DEVICE, MCT-F5, MCT-F50, MCT-F500
    Manufacturer
    NEWCARE PRODUCTS, LLC.
    Date Cleared
    2002-01-30

    (131 days)

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

    NEWCARE PRODUCTS, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Model 7500 Microcurrent TENS Device is intended to be used for the relief of chronic intractable pain.
    Device Description
    A number of TENS and microcurrent devices have been cleared for marketing by FDA that have just a few discrete output settings, rather than having a continuously adjustable output. Such devices have been shrinking in size in recent years as advances in integrated circuits and other components allow for smaller circuits. Now NewCare Products is introducing a microcurrent TENS device that has the generator unit builtin to the back of the electrodes. By eliminating the bulky controls, the generator may be made very small and can be mounted on the electrode pad. By providing three versions of the device, three different output levels The three versions of the Model 7500 are equivalent to are obtained. one traditional generator with three discrete output levels.
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