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510(k) Data Aggregation

    K Number
    K250046
    Device Name
    Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617)
    Manufacturer
    Shenzhen Urion Technology Co., Ltd.
    Date Cleared
    2025-04-25

    (105 days)

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

    Shenzhen Urion Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Air Compression Leg Massager is used to temporarily relieve mild muscle pains and discomfort, and temporarily increase blood circulation to the treatment areas in people who are in good health. Air Compression Leg Massager simulates kneading and stroking of tissues by using an inflatable garment.
    Device Description
    Air Compression Leg Massager is a portable and rechargeable device. It is intended to be an over-the-counter portable inflatable tube massage system which simulates kneading and stroking of tissue with the hands by use of inflatable pressure cuffs. It can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains. The models include UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617. All of them have same Indications for use, technological characteristics and similar device appearance. And they have the same electrical circuit design, PCB layout, critical components and internal wiring. The differences for them are software function, operation method for mode adjustment and the shape of compatible inflatable garment. Air Compression Leg Massager supplied clean and non-sterile, utilizes the pneumatically controlled leg wraps actuated by an electronically controlled air pump unit. A pump, battery and control components are protectively housed in a plastic case of the main body. The main body and the inflatable garment are not detachable. Function buttons and light emitting diode (LED) indicators on the main body make up the user interface. Each inflatable garment is connected to the main body by air hoses and encase a 2-chamber air bladder inside. Calves can be wrapped and massaged separately by the two chambers. The main unit is directly installed on the inflatable garment through tubes and fixing buckles, and there is no need for users to install it again. The soft medical fabric of wraps provides patient comfort and biocompatibility compliance. In operation, the user turns the power on via the Power button. Then the main body controls the inflating and deflating of the air bladders according to preset program.
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    K Number
    K141683
    Device Name
    ELECTRONIC BLOOD PRESSURE MONITOR
    Manufacturer
    SHENZHEN URION TECHNOLOGY CO., LTD.
    Date Cleared
    2015-04-03

    (284 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHENZHEN URION TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    U60 Series Wrist Electronic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the wrist. It can be used at medical facilities or at home. The intended wrist circumference is 13.5-21.5 cm.
    Device Description
    The proposed device, U60 Series Wrist Electronic Blood Pressure Monitor, is a battery driven automatic on-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at wrist within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or KPa. All the models included in this submission follow the same measurement principle and same specifications. The main differences are data storage and time display. These two differences will not affect the safety and effectiveness of the device.
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