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510(k) Data Aggregation

    K Number
    K162987
    Device Name
    FA100 SCCD (Sequential Continuous Contraction Device)
    Date Cleared
    2017-02-14

    (110 days)

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

    FlowAid Medical Technologies, Corp

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The FA100 SCCD is indicated for use in: - Increasing local blood circulation, - . Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, - Preventing or retarding disuse atrophy - Edema reduction
    Device Description
    The FA100 SCCD is a portable, battery powered, hand-held 4-channel electrical stimulator (single unit) intended to provide continuous, sequential stimulation of the calf muscles. The FA100 SCCD designed to be user friendly and simple to use, with a large liquid crystal display (LCD) screen that displays the treatment mode currently in use and the selected intensity level for the patient to select a comfortable therapy session as recommended by the patient's healthcare provider. The FA100 SCCD system provides three preset treatment programs, which enable the patient to choose among three pulse frequencies: - 1. 4 Hz (program AA) - 2. 9 Hz (program VE - the default setting of the device) - 3. 14 Hz (program PA) Pulse frequency is the only difference between the three programs and is selected for patient comfort during the treatment as recommended by the patient's healthcare provider. The stimulation provided by the FA100 SCCD rotates in a continuous, sequential pattern through the four channels. The rotation through the channels is directly related to the frequency setting, i.e., slowest for the 4 Hz program and fastest for the 14 Hz program. All programs effectively contract the muscles and increase blood flow. The only other parameter that can be varied is the stimulus intensity, which is set by the user to achieve the maximum tolerable contraction. Otherwise, the pulse shape (rectangular, symmetrical, bi-phasic), pulse width (500 µsec), and stimulation pattern (sequential channel activation) are the same for all three programs.
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