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510(k) Data Aggregation

    K Number
    K202898
    Device Name
    Tzoar 207 Negative Pressure Wound Therapy (NPWT) System
    Date Cleared
    2021-12-30

    (457 days)

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

    Lightstone Medical Products (Ningbo) Co Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Tzoar Negative Pressure Wound Therapy (NPWT) System is indicated for wound management via the application of negative pressure to the wound by the removal of wound exudate, infectious materials, and tissue debris from the wound bed. The Tzoar 207 Negative Pressure Wound Therapy (NPWT) System is indicated for the following wound types: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
    Device Description
    The Tzoar 207 Negative Pressure Wound Therapy (NPWT) System includes a pump and two types of dressings: Tzoar NPWT Foam Kits and Tzoar NPWT One Piece Dressing. The Tzoar 207 NPWT pump is a portable, battery powered pump which may promote wound healing through the drainage and removal of wound exudates, infectious material, and tissue debris from the wound bed using continuous and/or intermittent negative pressure. The Tzoar NPWT One Piece Dressing and the Tzoar NPWT Foam Kits are both Tzoar Wound Dressings intended to be used with an NPWT device to manage acute and chronic wounds.
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