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510(k) Data Aggregation

    K Number
    K241023
    Device Name
    Negative Pressure Wound Therapy Device (V-Move, V-Grand)
    Manufacturer
    Med Way Inc.
    Date Cleared
    2024-08-19

    (126 days)

    Product Code
    OMP
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    Med Way Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Negative Pressure Wound Therapy Device is indicated for wound management via the application of negative pressure to the wound by the removal of wound exudate, infectious materials, and tissue debris from the wound bed. The Negative Pressure Wound Therapy Device is indicated for the following wound types: chronic, acute, traumatic, subacute, and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps, and grafts.
    Device Description
    The Negative Pressure Wound Therapy Device is a portable, rechargeable, battery powered pump capable of delivering bespoke continuous and/or intermittent negative pressure intended to allow wound management by draining and removing wound exudates, infectious material, and tissue debris from the wound bed. The Negative Pressure Wound Device is packaged and provided with the following components: Negative Pressure Wound Therapy Pump and Collection Canister. Patients with chronic, acute, traumatic, subacute, and dehisced wounds, partial-thickness burns, diabetic ulcers, neuropathic ulcers, pressure ulcers, flaps, and grafts may benefit from this system. The Negative Pressure Wound Therapy Device used with wound dressings can produce a negative pressure environment in either intermittent or continuous mode. This allows the user to program the specific pressure ranging from 50mmHg to 200mmHg (V-Move) and 0 to 200 mmHg (V-Grand). In intermittent mode, the pump will alternate between applying pressure for 5 continuous minutes and reducing pressure to 0 for 2 minutes for V-Move. In intermittent mode, therapy pressure, operating time, and interval time can be adjusted for V-Grand. The Negative Pressure Wound Therapy Device is compatible with the Longterm NPWT Foam Dressing Kit (K211571). The device is used in professional medical facilities. The Negative Pressure Wound Therapy pump accessories that are included in this 510(k) submission and will be commercialized separately are the following: 300cc Collection Canister 500cc Collection Canister 1000cc Collection Canister
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