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510(k) Data Aggregation

    K Number
    K131159
    Device Name
    SMARTRELIEF
    Manufacturer
    CHATTEM, INC.
    Date Cleared
    2013-07-25

    (92 days)

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

    CHATTEM, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be used for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities. To be used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
    Device Description
    The SmartRelief is a transcutaneous electrical nerve stimulator for relief of muscular pain and sold without prescription. Key to its use are specially shaped electrodes that allow an untrained person to properly place them on the body. The device consists of a microprocessor and associated components powered by a coin cell and housed in a small plastic case. The controls for the device consist of three buttons: A power button which turns the device on and off, an intensity increase button, and an intensity decrease button. This simple user interface is further augmented by distinctive shapes to allow the user to identify the controls even if they cannot see the device. Contact to the body is made through self-adhesive electrodes. Electrical connection from the device to the electrode is made directly through snaps on the device and the electrode; no leadwires are used. The electrodes are designed with both conductive surfaces combined into a single piece. These electrodes are manufactured in various shapes to facilitate proper placement on the body.
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