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510(k) Data Aggregation

    K Number
    K240499
    Device Name
    ARTAIRA Arterial Compression Device (AACD01)
    Date Cleared
    2024-10-11

    (234 days)

    Product Code
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    AIROS Medical, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ARTAIRA Arterial Compression Device's is an intermittent pneumatic compression device intended for treatment of patients with the following conditions: - · Intermittent claudication - · Rest pain - Diabetic Foot - · Ischemic neuritis - · Arterial ulcers - · Gangrene - Poor runoff.
    Device Description
    The AIROS ARTAIRA Arterial Compression Device is an intermittent pneumatic compression device intended to increase blood flow and increase circulation in the lower extremities by providing timed compression to the foot/ankle and calf. The device consists of a hard casing with an air pump, a set of air valves, an air reservoir controlled by the device software to deliver a rapid burst of pneumatic pressure to the treatment area. The device connects through air tubing to a pair of compression garments (left and right leg), each with two air chambers: one on the underfoot (Foot/Ankle chamber) and one on the calf area (Calf Chamber). The device can either be used with one garment or two garments. The system is intended to be used primarily at home settings according to a physician-prescribed therapy.
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    K Number
    K223193
    Device Name
    AIROS 8P Sequential Compression Device
    Manufacturer
    Date Cleared
    2022-12-09

    (57 days)

    Product Code
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    AIROS Medical, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AIROS 8P Sequential Compression Device utilizes gradient pneumatic compression, which is intended for treatment of patients with the following conditions: - Lymphedema - Venous stasis ulcers - Venous insufficiency - Peripheral edema The device is safe for both home and hospital use.
    Device Description
    AIROS 8P Sequential Compression Device is a pneumatic compression device used for treatment and management of venous or lymphatic disorders. The application of compression is effective by increasing blood flow and encouraging extracellular fluid clearance. The device consists of the mechanical device that is used to set the treatment options and supplies cycles of air to the compression garments. There are three primary treatment modes, Gradient Mode, Pressure Mode, and Peristaltic Mode. The air is supplied at adjustable pressures and sequences and inflates the compression garments from the distal to proximal areas of the body. The compression garments are supplied in various sizes for the upper and lower extremity areas of the body.
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    K Number
    K223195
    Device Name
    AIROS 6P Sequential Compression Device
    Manufacturer
    Date Cleared
    2022-12-09

    (57 days)

    Product Code
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    AIROS Medical, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AIROS 6P Sequential Compression Device utilizes gradient pneumatic compression, which is intended for treatment of patients with the following conditions: - Lymphedema - Venous stasis ulcers - Venous insufficiency - Peripheral edema The device is safe for both home and hospital use.
    Device Description
    AIROS 6P Sequential Compression Device is a pneumatic compression device used for treatment and management of venous or lymphatic disorders. The application of compression is effective by increasing blood flow and encouraging extracellular fluid clearance. The device consists of the mechanical device that is used to set the treatment options and supplies cycles of air to the compression garments. There are two primary treatment modes, Gradient Mode and Peristaltic Mode. The air is supplied at adjustable pressures and sequences and inflates the compression garments from the distal to proximal areas of the body. The compression garments are supplied in various sizes for the upper and lower extremity areas of the body.
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    K Number
    K193068
    Device Name
    AIROS 8 Sequential Compression Device
    Date Cleared
    2019-12-04

    (30 days)

    Product Code
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    AIROS Medical, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AIROS 8 Sequential Compression Device utilizes gradient pneumatic compression, which is intended for treatment of patients with the following conditions: - Lymphedema - Venous stasis ulcers - Venous insufficiency - Peripheral edema The device is safe for both home and hospital use.
    Device Description
    The AIROS 8 Sequential Compression Device is a gradient pneumatic compression device. The device is used for treatment and management of venous or lymphatic disorders. The application of gradient sequential compression increases blood flow and encourages extracellular fluid clearance. The AIROS 8 system consists of the device and 8-chambered garments. The device provides cycles of compressed air and sequentially inflates the garments from distal to proximal. The digitally-controlled device consists of an electrically generated source of compressed air, tubing to convey the pressurized air to the sleeve, and like the predicate, pressure is applied cyclically for a specified period of time, according to the physician's prescription.
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    K Number
    K193069
    Device Name
    AIROS 6 Sequential Compression Device
    Date Cleared
    2019-12-04

    (30 days)

    Product Code
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    AIROS Medical, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AIROS 6 Sequential Compression Device utilizes gradient pneumatic compression, which is intended for treatment of patients with the following conditions: - Lymphedema - Venous stasis ulcers - Venous insufficiency - Peripheral edema The device is safe for both home and hospital use.
    Device Description
    The AIROS 6 Sequential Compression Device is a gradient pneumatic compression device. The device is used for treatment and management of venous or lymphatic disorders. The application of gradient sequential compression increases blood flow and encourages extracellular fluid clearance. The AIROS 6 system consists of the device and 6-chambered garments. The device provides cycles of compressed air and sequentially inflates the garments from distal to proximal.
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    K Number
    K172770
    Device Name
    AIROS 6 Sequential Compression Device
    Date Cleared
    2018-06-22

    (281 days)

    Product Code
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    AIROS Medical, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AIROS 6 Sequential Compression Device utilizes gradient pneumatic compression, which is intended for treatment of patients with the following conditions: - · Lymphedema - Venous stasis ulcers - · Venous insufficiency - · Peripheral edema The device is safe for both home and hospital use.
    Device Description
    The AIROS 6 Sequential Compression Device is a gradient pneumatic compression device. The device is used for treatment and management of venous or lymphatic disorders. The application of gradient sequential compression increases blood flow and encourages extracellular fluid clearance. The AIROS 6 system consists of the device and 6-chambered garments. The device provides cycles of compressed air and sequentially inflates the garments from distal to proximal.
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    K Number
    K172779
    Device Name
    AIROS 8 Sequential Compression Device
    Date Cleared
    2018-06-22

    (281 days)

    Product Code
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    AIROS Medical, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AIROS 8 Sequential Compression Device utilizes gradient pneumatic compression, which is intended for treatment of patients with the following conditions: - · Lymphedema - Venous stasis ulcers - · Venous insufficiency - · Peripheral edema The device is safe for both home and hospital use,
    Device Description
    The AIROS 8 Sequential Compression Device is a gradient pneumatic compression device. The device is used for treatment and management of venous or lymphatic disorders. The application of gradient sequential compression increases blood flow and encourages extracellular fluid clearance. The AIROS 8 system consists of the device and 8-chambered garments. The device provides cycles of compressed air at certain adjustable pressures, and sequentially inflates the garments from distal to proximal. The pressure at each chamber can be individually adjusted to accommodate different therapy needs.
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