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    K Number
    K052625
    Device Name
    BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000
    Manufacturer
    BIONICARE MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2005-12-05

    (73 days)

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

    BIONICARE MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BioniCare Stimulator, Model BIO-1000™, is indicated for use as an adjunctive therapy in reducing the level of pain, and stiffness associated with pain, from rheumatoid arthritis of the hand.
    Device Description
    The BIO-1000 is a portable, rechargeable, battery-operated dual-channel device that utilizes a voltage regulated output circuit to generate a spike-shaped monophasic pulse with an adjustable amplitude of 0-12 volts peak and repeating at a single fixed frequency of 100 ± 5 Hertz. The device consists of electrodes, lead wires and a signal generator.
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    K Number
    K030332
    Device Name
    MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000
    Manufacturer
    BIONICARE MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2003-06-06

    (126 days)

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

    BIONICARE MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BioniCare® Stimulator, Model BIO-1000™ is indicated for use as an adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee and for overall improvement of the knee as assessed by the physician's global evaluation (clinical studies.)
    Device Description
    The BioniCare® Stimulator, Model BIO-1000™ consists of the electrodes, the lead wires, and the BioniCare Stimulator. The stimulator is portable, battery operated and rechargeable. The lead wires connect the electrodes to the stimulator. These electrodes complete an electrical circuit allowing current flow. The stimulator produces a pulsed electrical signal through the lead wires and electrodes at the treatment site.
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