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510(k) Data Aggregation

    K Number
    K213906
    Device Name
    extriCARE 1000 Negative Pressure Wound Therapy System
    Manufacturer
    Date Cleared
    2023-03-08

    (449 days)

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

    Alleva Medical Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The extriCARE® 1000 NPWT System is intended to generate negative pressure to remove wound exudates, infectious material, and tissue debris from the wound bed. The extriCARE® 1000 NPWT System is intended for use in wounds with low to moderate levels of exudate. Appropriate wound types include: - Chronic wounds - Acute wounds - · Traumatic wounds - · Subacute and dehisced wounds - · Partial-thickness burns - · Ulcer wounds (such as diabetic or pressure) - · Flaps and grafts - · Closed surgical incisions The extriCARE 1000 NPWT System is intended for use in healthcare facilities.
    Device Description
    The extriCARE 1000 Negative Pressure Wound Therapy (NPWT) system consists of a portable, battery-powered pump unit intended to generate vacuum pressure to remove low to moderate level of wound exudates, infectious material, and tissue debris from the wound bed. Three preset vacuum pressures can be selected by the user - 80, 100, and 125mmHg. The extriCARE 1000 is packaged and provided with the following components: - 1. extriCARE 1000 Negative Pressure Wound Therapy Pump - 2. extriCARE 1000 50cc Collection Canister The extriCARE 1000 Negative Pressure Wound Therapy (NPWT) Pump accessory that is included in this 510(k) applications and will be commercialized separately is the extriCARE 1000 50cc Collection Canister (additional cannister replacements).
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