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510(k) Data Aggregation

    K Number
    K093999
    Device Name
    ARP POV SPORT
    Date Cleared
    2010-08-10

    (225 days)

    Product Code
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARP MANUFACTURING, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ARP POV Sport is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The ARP POV Sport is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. The ARP POV Sport is not designed for use on injured or ailing muscles and its use on such muscles is contraindicated. The POV Sport's electrical impulses allow triggering action potential on motoneurones of motornerves (excitations). These excitations of motoneurones are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles. The various types of muscle work that the POV Sport can impose on the stimulated muscles are able to improve or facilitate muscle performance. The ARP POV Sport is considered a technique of muscle training.
    Device Description
    The system consists of a table top electrical generator producing optimal continuous or interrupted electrical impulses through patient electrodes. Control parameters are software controlled through an LCD touch screen.
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    K Number
    K093259
    Device Name
    ARP RX100
    Date Cleared
    2009-12-17

    (59 days)

    Product Code
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARP MANUFACTURING, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ARP Rx100 is intended for the following applications: - Relaxation of muscle spasms - Prevention or retardation of disease atrophy - Increasing local blood circulation - Muscle re-education - Maintaining or increasing range of motion
    Device Description
    The system consists of a table top electrical generator producing optimal continuous or interrupted electrical impulses through patient electrodes. Control parameters are software controlled through an LCD touch screen.
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