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510(k) Data Aggregation

    K Number
    K112634
    Device Name
    NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP
    Manufacturer
    INOTEC AMD LTD.
    Date Cleared
    2012-07-03

    (298 days)

    Product Code
    KPJ
    Regulation Number
    878.5650
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K023456,K090681
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The NATROX™ System is a low-dose tissue oxygenation system intended to provide topical oxygen to aid in the healing of chronic wounds such as:

    • Skin ulcerations due to diabetes, venous stasis, post-surgical infections and gangrenous lesions,
    • Decubitis ulcers (bedsores), .
    • Amputations/infected stumps, .
    • Skin grafts,
    • Burns, and
    • Frostbite
    Device Description

    The NATROX™ Topical Oxygen Delivery System is a small battery-powered electronic device approximately the size of a cell phone, containing an oxygen generator that produces 99% oxygen from room air at a rate of approximately 13 mL/hour. A small diameter tube transmits the oxygen to the wound bed, where the wound is exposed to the oxygen atmosphere inside the Oxygen Delivery System (ODS), Island Oxygen Delivery Pad (IODP) wound dressing or into the patient's own wound dressing, The NATROX™ System provides oxygen to diffuse evenly over the wound bed under an occlusive dressing, constantly refreshing the oxygen supply to enhance the normal process of wound healing for chronic and hard-to-heal wounds with compromised oxygen delivery to healing tissue.

    AI/ML Overview

    The provided text describes the NATROX™ Topical Oxygen Delivery System and its safety and effectiveness. However, it does not contain specific acceptance criteria in a quantifiable format (e.g., "wound size reduction of X% with p-value

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