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510(k) Data Aggregation

    K Number
    K212491
    Device Name
    Air Relax Pro Model AR-4.0
    Date Cleared
    2021-09-02

    (24 days)

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

    Diode Art Engineering doing business as Air Relax

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Air Relax Pro Model AR-4.0 is intended for the temporary relief of minor muscle aches and for temporary increase in circulation to the treated areas in people who are in good health. The Air Relax Pro Model AR-4.0 simulates kneading and stroking of tissues by using an inflatable garment.
    Device Description
    This submission is for the Diode Art Engineering Air Relax Pro Model AR-4.0. The Air Relax Pro Model AR-4.0 is a powered inflatable tube massager. It is intended to temporarily relieve minor muscle aches and pains, and to temporarily increase circulation to the treated areas. It simulates manual kneading and stroking of tissues by use of an inflatable pressure cuff. The device is to be used by people who are in good health. The device is a Class II, type BF applied part that receives power a separately approved external IEC 60601-1 compliant power supply or optional battery pack. The Air Relax Pro Model AR-4.0 consists of an air compressor unit with a control system, an inflatable "garment" (arms, legs and hips), plastic air tubing with a proprietary connector for connecting the device to the garment. A description of each of these components is provided below. The hip garment is also referred to as "shorts". The user interface is a front panel display and buttons. The Air Relax Pro Model AR-4.0 contains an air compressor with a system control that that allows the user to adjust the amount of air coming from the air compressor and going to the individual segments of the inflatable garment. There is no electrical contact with the user and the device does not transfer or detect energy to or from the user. The user interface of the Air Relax Pro Model AR-4.0 provides for starting and stopping the massage treatment, allows for adjusting time and intensity (pressure) of the treatment. The device also provide a proprietary keyed connector to the tubing which connects to the garment. The tubing connector at the garment is also proprietary. The proprietary connectors ensure that neither the device, tubing nor garment can be misconnected to any other device or garment. Pressure selection is performed by pressing pressure button multiple times. Pressure level is selectable between 40 and 170 mmHg There are four modes (Progressive, Sequential, Drain and Overlay) that determine the inflation sequence of the cells within the garments.
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    K Number
    K211460
    Device Name
    Air Relax Plus Model AR-3.0
    Date Cleared
    2021-05-25

    (14 days)

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

    Diode Art Engineering doing business as Air Relax

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Air Relax Plus Model AR-3.0 is intended for the temporary relief of minor muscle aches and for temporary increase in circulation to the treated areas in people who are in good health. The Air Relax Plus Model AR-3.0 simulates kneading and stroking of tissues by using an inflatable garment.
    Device Description
    This submission is for the Diode Art Engineering Air Relax Plus Model AR-3.0. The Air Relax Plus Model AR-3.0 is a powered inflatable tube massager. It is intended to temporarily relieve minor muscle aches and pains, and to temporarily increase circulation to the treated areas. It simulates manual kneading and stroking of tissues by use of an inflatable pressure cuff. The device is to be used by people who are in good health. The device is a Class II, type BF applied part that receives power from a separately approved external IEC 60601-1 compliant power supply or optional battery pack. The Air Relax Plus Model AR-3.0 consists of an air compressor unit with a control system, an inflatable "garment" (arms, legs and hips), plastic air tubing with a proprietary connector for connecting the device to the garment A description of each of these components is provided below. The hip garment is also referred to as "shorts". The user interface is a front panel display and buttons. The Air Relax Plus Model AR-3.0 contains an air compressor with a system control that allows the user to adjust the amount of air coming from the air compressorand going to the individual segments of the inflatable garment. There is no electrical contact with the user and the device does not transfer or detect energy to or from the user. The user interface of the Air Relax Plus Model AR-3.0 provides for starting and stopping the massage treatment, allows for adjusting time and intensity (pressure) of the treatment. The device also provides a proprietary keyed connector to the tubing which connects to the garment. The tubing connector to the garment is also proprietary. The proprietary connectors ensure that neither the device, tubing nor garment can be misconnected to any other device or garment. Pressure selection is performed by pressing pressure button multiple times. There are four pressure levels with approximate pressure levels as below: Level 1: 60 mmHg Level 2: 100 mmHg Level 3: 140 mmHg Level 4: 170 mmHg There are three modes (Progressive, Sequential, Full massage P, S and F) that determine the inflation sequence.
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