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510(k) Data Aggregation

    K Number
    K111557
    Device Name
    X-FORCE
    Date Cleared
    2011-11-10

    (160 days)

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

    SEVEN SEAS DISTRIBTION AND MANUFACTURING LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The X-Force external, non-invasive, non-narcotic, clectrotherapy system is indicated for use as an adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee. The X-Force is also indicated for use as an adjunctive therapy in reducing the level of pain, and stiffess associated with pain, from rheumatoid arthritis of the Hand. These devices are to be used or sold only under the direct supervision or order of a licensed practitioner. A prescription is required to obtain this product can be used in the home or clinic by all patients in need.
    Device Description
    The X-FORCE device is a microcomputer controlled digital device featuring a NT Mode output. The device provides simple programming facility to customize the treatment. The panel and its keys provide easy selection for treatment. It is device that deploys the use of electrotherapy and compression to treat Osteoarthritis (OA) and rheumatoid arthritis of the knee or hand. The X-Force consists of electrodes, the lead wires, and the signal generator. The device is portable and rechargeable battery operated. The lead wires connect the electrodes to the device. These electrodes complete an electrical circuit allowing current to flow. The stimulator produces a pulsed electrical signal through the lead wires and electrodes at the treatment site.
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