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510(k) Data Aggregation

    K Number
    K200285
    Device Name
    VenaOne
    Manufacturer
    Date Cleared
    2020-07-02

    (148 days)

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

    Vena Group, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    VenaOne is an easy to use system prescribed by healthcare professionals for stimulating blood flow in the legs (simulating muscle contractions) that aids in the prevention of DVT, enhances blood circulation, diminishes post-operative pain and swelling, reduces wound healing time, and aids in the treatment and healing of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency, and reduction of edema in the lower limbs.
    Device Description
    The VenaOne is a lightweight, portable battery powered prescriptive device. It is intended for stimulating blood flow in the legs (simulating muscle contractions) that helps stimulate blood flow as an aid in the prevention of deep vein thrombosis (DVT). Its portable design allows patients to wear the unit during many clinical related activities, such as physical therapy sessions, wheel chair transportation, cafeteria sittings, and during general mobility throughout the clinic. As an easy to use system. VenaOne utilizes the pneumatically controlled chamber cuff actuated by an electronically controlled air pump unit and solenoid valve. All the pump and control components are protectively housed in a plastic case of the control unit that is permanently attached to an inflatable air bladder. An ON/OFF button, a display, and a battery icon provide for user interface. There is also a charging port for connecting the battery charger/AC adapter plug, and a USB cable port for connecting the VenaOne device to the computer for tracking patient device use time. The detachable rechargeable battery could be mounted on the control unit or on the separate charging station for charging. Prior to use, the cut-resistant air bladder and control unit are placed inside a disposable medical fabric or equivalent medical material. The VenaOne devices are supplied clean and non-sterile. In operation, the device could be powered on via the single ON/OFF button. The control unit then fills the air bladder to a pre-determined pressure (55 mmHg). The pressure of the air bladder is monitored by an internal pressure switch and system software. Once the pressure reaches the proper level, the pump is turned off, and the air bladder deflates to the ambient pressure through a valve inside the plastic case of the control unit. After the "rest" period of approximately 50 seconds, the cycle repeats until the unit is turned off.
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