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510(k) Data Aggregation

    K Number
    K983228
    Device Name
    BIONICARE STIMILATOR SYSTEM, MODEL BIO-1000
    Manufacturer
    MURRAY ELECTRONICS
    Date Cleared
    1999-03-15

    (181 days)

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

    MURRAY ELECTRONICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bionicare Stimulator System Model BIO-1000" is indicated for use as an adjunctive therapy in reducing the level of pain, and stiffiess associated with pain, from rheumatoid arthritis of the hand.
    Device Description
    The Bionicare Stimulator System, Model BIO-1000" is a rechargeable battery operated TENS stimulator that utilizes a voltage regulated output circuit to generate a spike-shaped pulse with an adjustable amplitude of 0-12 volts peak and repeating at a single fixed frequency of 100 ± 5 Hertz. Electrodes are applied to the hand and arm using a standard clectrode gel, Spectra 360 (Parker Laboratories NDC 341-0012-08). The signal is applied across the cathodic hand electrode and the anodic arm electrode.
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    K Number
    K971437
    Device Name
    BIONICARE STIMULATOR SYSTEM. MODEL BIO-1000
    Manufacturer
    MURRAY ELECTRONICS
    Date Cleared
    1997-07-22

    (95 days)

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

    MURRAY ELECTRONICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bionicare® Stimulator System 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 (see clinical studies).
    Device Description
    The Bionicare® Stimulator, Model BIO-1000 is a rechargeable battery operated TENS stimulator that utilizes a voltage regulated output circuit to generate a spike-shaped pulse with an adjustable amplitude of 0-12 volts peak and repeating at a single fixed frequency of 100 + 5 Hertz. Electrodes are applied to the knee and thigh using a standard electrode gel, Spectra 360 (Parker Laboratories NDC 341-0012-08), The signal is applied across the cathodic knee electrode and the anodic thigh electrode.
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