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510(k) Data Aggregation

    K Number
    K212935
    Device Name
    Air Pressure Foot Massager
    Manufacturer
    Xiamen Simo Electronic Co., Ltd
    Date Cleared
    2022-02-19

    (157 days)

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

    Xiamen Simo Electronic Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Air Pressure Foot Massager is intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.
    Device Description
    Air Pressure Foot Massager has a pump. The pump is connected with the dedicated inflatable sleeve through the hose, one sleeve has 2 compression chambers. The pump compresses and inflates air into the chambers continuously to produce compression from the body tail end to body center and release the air after compression as one cycle process. The device is equipped with a hand controller. In operation, the user simply turns the power on via the power button. The intensity (pressure) can be adjusted by purpose to avoid any discomfort. The device is powered by an external IEC 60601-1 compliant power supply and can also be powered by an internal IEC 62133-compliant lithium-ion battery. The materials of sleeve use medical fabric or equivalent medical material for increased patient comfort and biocompatibility compliance. The Air Pressure Foot Massager is a portable and rechargeable device. It is intended to be an over-the-counter portable inflatable tube massage system which simulates kneading of tissue by use of an inflatable sleeve. It can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains.
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