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510(k) Data Aggregation

    K Number
    K240981
    Device Name
    Air compression leg massager
    Date Cleared
    2024-08-02

    (114 days)

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

    Huizhou XINYI Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The air compression leg massager is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The air compression leg massager simulates kneading and stroking of tissues by using an inflatable garment.
    Device Description
    Not Found
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    K Number
    K221862
    Device Name
    YY-A02-B Overlapped Compression Therapy
    Date Cleared
    2022-12-08

    (164 days)

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

    Huizhou XINYI Technology Co., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Overlapped Compression Therapy is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in pood health. The Overlapped Compression Therapy simulates kneading and stroking of tissues by using an inflatable garment.
    Device Description
    The Overlapped Compression Therapy consists of leg sleeve and control device working together as one unit. The Overlapped Compression Therapy mainly forms the circulating pressure on the limbs and tissues by repeatedly inflating and deflating the multi cavity chambers in sequence, and evenly, orderly and properly extrudes the distal end of the limbs to the proximal end of the limbs.
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