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510(k) Data Aggregation

    K Number
    K161570
    Device Name
    Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam Wound Dressing Kit-Large
    Date Cleared
    2016-08-29

    (83 days)

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

    LC Medical Concepts, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Theia NPWT Foam Wound Dressing Kit is intended to be used in conjunction with the Simex Negative Pressure Wound Therapy Pumps (K113291) for the application of negative pressure wound therapy to the wound. When used in conjunction with the Simex Negative Pressure Wound Therapy Pumps, the Theia NPWT Foam Wound Dressing Kit is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of excess exudates, infectious material and tissue debris. The Theia NPWT Foam Wound Dressing Kit is appropriate for use on the following wounds; - Pressure Ulcers - · Diabetic/Neuropathic Ulcers - Venous Insufficiency Ulcers - · Traumatic Wounds - · Post-Operative and Dehisced Surgical Wounds - · Skin Flap and Grafts
    Device Description
    The Theia NPWT Foam Wound Dressing Kit without the pump includes a foam dressing composed of a reticulated flexible polyether based polyurethane hydrophobic foam material, an occlusive drape and silicon suction dome with negative pressure tubing. Theia NPWT Foam Wound Dressing Kits are available in three sizes; 1) small, 2) medium and 3) large.
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