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510(k) Data Aggregation

    K Number
    K211850
    Device Name
    Air Compression Leg Massager (model: FE-7204B)
    Date Cleared
    2022-03-03

    (261 days)

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

    Xiamen Healthpal Electronic Co.,Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Air compression leg massager, model:FE-7204B, is intended for the temporary relief of minor muscle aches and for the temporary increase in circulation to the treated foot/calf and thigh in people who are in good health. The air compression leg massager simulates kneading and stroking of tissues by using air-inflatable boots.
    Device Description
    The Air Compression Leg Massager (model: FE-7204B) is a powered inflatable tube massager intended to be an over-the counter portable tube massage system which simulates kneading and stroking of foot, calf, and thigh by the use of inflatable air compression boots. The device can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains. The device is to be used by persons who are in good health. The device is non-sterile and utilizes the pneumatically controlled chambers actuated by an electronically controlled air pump and two solenoid valves. The pump, solenoids and other components are protectively housed within the acrylonitrile butadiene styrene (ABS) plastic enclosure of the control unit. On the bottom of the control unit, there are 3 ports which include the following: . Two ports (L and R) for connecting the air compression boots (left (L) and right (R)) by the air hose which is permanently attached to the air compression boots . One port for connecting the alternating current (AC) adaptor which will convert line power into direct current (DC) power. The subject device is comprised of the following components: - Control Unit - AC Adapter (input:100-240V AC 50/60Hz 0.7A, output 12.0VDC, 2.0A) for converting line power to DC power - Connector Air Hose (connects Control Unit to the inflatable air compression boots) - Air compression boots which consist of three (3) air chambers/bladders encased inside a soft medical material.
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