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510(k) Data Aggregation

    K Number
    K033358
    Device Name
    CHRONIC PAIN SUPPRESSOR CPS-2000, MODEL CPS-2000
    Manufacturer
    SURGITECH, INC.
    Date Cleared
    2003-11-14

    (25 days)

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

    SURGITECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Symptomatic relief of chronic intractable pain - Adjunctive treatment for the management of post-traumatic or post-surgical pain
    Device Description
    The Chronic Pain Suppressor CPS-2000 is a rechargeable battery operated Interferential Current Therapy device that utilizes an output circuit to generate a symmetric monophasic sine or square waveform of electrical current. Delivered along a patient cable and lead wires to electrodes placed on the skin. The physician prescribed and programmed output passes through the skin and actives the underlying nerves. The symptomatic relief from chronic intractable pain can be obtained from this electrical stimulation.
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    K Number
    K031576
    Device Name
    SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1
    Manufacturer
    SURGITECH, INC.
    Date Cleared
    2003-07-31

    (72 days)

    Product Code
    IQI
    Regulation Number
    890.3475
    Why did this record match?
    Applicant Name (Manufacturer) :

    SURGITECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An orthosis worn on the wrist for medical purposes: - to support and/or immobilize for functional improvement. - for conservative treatment of symptoms affiliated with Carpal Tunnel Syndrome, repetitive motion type injuries, sprains, strains and similar injuries of the wrist. - to keep wrist motion to a minimum while worn allowing the body to recover from the damage of repetitive motion or other injuries. - to provide temporary relief of associated symptoms of some wrist conditions.
    Device Description
    Not Found
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