Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K103738
    Device Name
    H-WAVE
    Date Cleared
    2011-06-01

    (161 days)

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

    ELECTRONIC WAVEFORM LABORATORY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The H-Wave® is indicated for the following conditions: 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; and 6. Maintaining or increasing range of motion.
    Device Description
    The H-Wave® model H4 is a portable battery operated electrical stimulation device with two channels, two sets of lead wires, three packages of self-adhesive electrodes, and a battery charger. Each channel has a pair of buttons to select the desired frequency and a dial to control the intensity of the signal. The stimulator also is supplied with an output jack for each channel, a charging jack, timer buttons, and an LCD display. The device creates therapeutic muscle contractions at frequencies of 1-70 Hz depending on the physician instructions and patient settings.
    Ask a Question

    Ask a specific question about this device

    K Number
    K081998
    Device Name
    H-WAVE SPORT
    Date Cleared
    2009-07-09

    (360 days)

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

    ELECTRONIC WAVEFORM LABORATORY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The H-Wave Sport is intended for muscle conditioning by stimulating muscle in order to improve or facilitate muscle performance. The H-Wave Sport is not intended to be used for therapy or treatment of medical diseases or medical conditions.
    Device Description
    The H-Wave® Sport consists of: a portable, battery operated neuromuscular stimulator with two channels, two sets of lead wires, two packages of self-adhesive electrodes and a battery charger. The H-Wave Sport stimulator is equipped with two simple dials that increase the intensity for each channel, output jacks for each channel, and a battery level indicator.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1