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510(k) Data Aggregation

    K Number
    K223464
    Device Name
    Leg and Foot Air Wave Pressure Therapy Device
    Manufacturer
    Zhangzhou Easepal Innovation Co Ltd.
    Date Cleared
    2023-03-14

    (117 days)

    Product Code
    IRP
    Regulation Number
    890.5650
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    Applicant Name (Manufacturer) :

    Zhangzhou Easepal Innovation Co Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Leg and Foot Air Wave Pressure Therapy Device EP-1129 is intended for the temporary relief of minor muscle aches and pains and for the temporary increase in circulation to the treated areas in pood health, it can simulate kneading and stroking of tissues by using an inflatable garment.
    Device Description
    Leg and Foot Air Wave Pressure Therapy Device EP-1129 is a powered inflatable tube massager, comprised of an air compressor with intermittent pneumatic controller. 3-chamber sleeves covered with polyester fiber, and a connectable hose for connecting the device to the sleeves. The device can be powered by an external power supply, or be powered by an internal lithium ion battery. The sleeves have 3-chambers and different applicable body areas, such as the Foot Leg. The sleeves can be inflating and deflating sequentially to apply the circulating pressure on the target body areas which controlled by the main unit. The device simulates manual kneading and stroking of tissues by sequential inflated sleeves, to temporarily relieve minor muscle aches and/or pains and to temporarily increase circulation to the treated areas. It is to be used by adults who are in good health. The recommended treatment time is 15 minutes per time, and recommend to take one time treatment every two days.
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