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510(k) Data Aggregation

    K Number
    K210281
    Device Name
    Fist Assist Devices Model FA-1
    Date Cleared
    2021-06-17

    (136 days)

    Product Code
    Regulation Number
    890.5650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Fist Assist Devices, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Fist Assist Model FA-1 is an arm massager intended to temporarily relieve minor muscle aches and to temporarily increase circulation to the treated areas.
    Device Description
    The Fist Assist Model FA-1 is a wearable, non-sterile, battery operated, intermittent pneumatic compression device for use on the arm over clothing. It is composed of two major components that are permanently attached to one another: 1. the control module that contains the electronics with miniature pump and 2. the wrap made of elastic cloth that holds the control module and internal air bladder and uses hook tape for attachment to any part of the wrap exterior. The control module and wrap are integral and permanently attached. It is powered by (2) AA batteries. The Fist Assist Model FA-1 has a single operation mode. When powered on by depressing the single push button switch, it goes through pressure cycles wherein the air bladder inflates to 60 mmHg and is held at that pressure for 20 seconds; the air bladder is then deflated and a minimal pressure of 10 mmHg (or less) and is held for 55 seconds until the next inflation to 60 mmHg begins again. The cycle repeats continuously until the power is turned off using the single push button switch. The device will turn off automatically after 1 hour of continuous use. When wearing this device, the device should only be used over full clothing and never on direct skin.
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