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510(k) Data Aggregation

    K Number
    K212169
    Device Name
    Air compression therapy system FO3002
    Date Cleared
    2021-11-23

    (134 days)

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

    Foshan Hongfeng Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Air compression therapy system FO3002 is intended for home to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.
    Device Description
    Air compression therapy system FO3002 is consist of air pressure sensor, air pump, sleeves etc working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses. The compression massage direction is from limb end to body center by inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The sleeve works under the action of sensor and microprocessor. Air compression therapy system FO3002, in medical market, it has a sequential squeezing from distal to proximal, thus help to improve circulation to the treated areas. Clothing should be worn between the device and the patient's skin.
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    K Number
    K201982
    Device Name
    Air compression therapy system FO-3001; Air compression therapy system FO-3008
    Date Cleared
    2021-03-25

    (251 days)

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

    Foshan Hongfeng Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Air compression therapy system Models FO-3001 and FO-3008: Intended for home to temporarily relieve minor muscle aches and/or pains, promote blood circulation in the treated areas.
    Device Description
    Air Pressure Therapy System is consist of air pressure sensor, air pump, sleeves etc working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses. The compression massage direction is from limb end to body center by inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The sleeve works under the action of sensor and microprocessor. Air Pressure Therapy System, in medical market, it has a sequential squeezing from distal to proximal, thus help to improve the circulation of blood.
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    Ask a specific question about this device

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