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510(k) Data Aggregation

    K Number
    K022028
    Device Name
    VX-400 TOPICAL HYPERBARIC OXYGEN CHAMBER
    Manufacturer
    Date Cleared
    2002-12-17

    (179 days)

    Product Code
    Regulation Number
    878.5650
    Why did this record match?
    Applicant Name (Manufacturer) :

    VASCULAR ONE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For Treatment of open acute or chronic wounds, e.g., - Skin ulcerations due to diabetes, venous stasis, post surgical infections and gangrenous lesions - Decubitus ulcers - Amputations/infected stumps - Skin grafts - Burns - Frostbite
    Device Description
    The VX-400 Topical Hyperbaric Oxygen Chamber is a small, portable system that provides oxygen, at prescribed pressure for a prescribed duration, to a patient's limb. It is used at home or a clinical setting to help speed wound healing. The system consists of five (5) major components: - 1. The Blue/Clear Plastic Chamber - 2. The Control Unit - 3. The Hand Held Controller - 4. The Silicone Sleeve - 5. Power Cube (Power Supply) The VX-400 is a rectangular, yet rounded (10 x 24 x 16) rigid plastic shell constructed of two plastic half-panels, to which epoxy is applied and then heat-sealed together along the edges to form one chamber. The chamber is a rigid plastic sleeve into which the patient places their limbs. There are two (2) hose barbs on the chamber, one for oxygen tubing that fills the chamber, and one for tubing to a pressure sensor. The controller consists of a plastic box with two (2) pieces of attached clear flexible tubing; these connect to the two (2) barbs on the chamber. The controller has a hose connected from the 50-psi oxygen source, a connector for a "power cube" that plugs into an AC wall outlet, and a cable that connects to the hand controller. The controller also incorporates a flowmeter. The hand-held controller can be programmed by the clinician to the prescribed time and pressure therapy, and then set to allow the patient to only turn the unit on and then off; it has a small 2 line LCD alphanumeric display and several push buttons.
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