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510(k) Data Aggregation

    K Number
    K251646
    Date Cleared
    2025-10-03

    (127 days)

    Product Code
    Regulation Number
    878.4780
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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. The extriCARE® 1000 NPWT System is intended for use with extriCARE® 1000 Bandage Dressings.

    Device Description

    The extriCARE® 1000 Negative Pressure Wound Therapy (NPWT) System consists of a portable 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 NPWT System is packaged and provided with the following components:

    1. extriCARE® 1000 Negative Pressure Wound Therapy Pump
    2. extriCARE® 1000 50cc Collection Canister
    3. Adapter Power Cord(5VDC)
    4. extriCARE® 1000 Bandage Dressing/K140634 (this component is provided separately)
    AI/ML Overview

    N/A

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