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510(k) Data Aggregation

    K Number
    K041063
    Device Name
    SMARTWAVE MS 2000
    Manufacturer
    NEWWAVE MEDICAL LLC
    Date Cleared
    2004-12-01

    (222 days)

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

    NEWWAVE MEDICAL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - 1. Relaxation of muscle spasms - 2. Prevention or retardation of disuse atrophy - 3. Increasing local blood circulation - 4. Muscle re-education - 5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - 6. Maintaining or increasing range of motion
    Device Description
    The Smartwave MS 2000 Muscle Stimulator is a Square wave generator designed for neuromuscular electrical stimulation (NMES). The MS 2000 stimulates neuromuscular tissues through cutaneous electrodes connected by lead wires to the generator.
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    K Number
    K003631
    Device Name
    SMARTWAVE IF 2000
    Manufacturer
    NEWWAVE MEDICAL LLC.
    Date Cleared
    2001-08-10

    (259 days)

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

    NEWWAVE MEDICAL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993130
    Device Name
    ULTRA-GARMENT ELECTRODE
    Manufacturer
    NEWWAVE MEDICAL LLC.
    Date Cleared
    1999-12-17

    (88 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEWWAVE MEDICAL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The "Ultra Garment Electrode" is intended to be used as an electrically conducting garment to be prescribed for usage by a physician for use where an electrode is appropriate. ULTRA GARMENTS: ARE USED WITH LEGALY MARKETED TRANSCUTAINEIOUS ELECTRICAL NERVE STIMULATORS, (LE.N.S.), HIGH VOLT PULSED GAVINIC STIMULATORS, (H.V.P.G.), AND INTERFERENTIAL. (INF), UNITS.
    Device Description
    The Ultra Garment Electrode is a Stretchable Electrically Conductive glove, sock, or sleeve, Reusable.
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