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510(k) Data Aggregation

    K Number
    K113236
    Device Name
    FORYOU NPWT DEVICE
    Date Cleared
    2013-02-12

    (468 days)

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

    FORYOU MEDICAL ELECTRONICS CO, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Foryou NPWT NP32 Device is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing through the removal of excess exudates, infectious material, and tissue debris.
    Device Description
    Foryou NPWT NP32 Device is an AC-powered, portable suction pump with a back-up battery. The pump is used in combination with wound dressing kits, a bacteria filter, suction tubing, drainage tubing, and a disposable canister. Foryou NPWT NP32 Device is designed for hospital use only with specified wound dressing kits to deliver a recommended therapeutic range of -55mmHg of continuous or intermittent negative pressure wound therapy to the wound, which may promote wound healing through the removal of excess exudates, infectious material, and tissue debris by: - preparing the wound bed for closure - reducing edema - promoting granulation tissue formation and perfusion - removing exudate and infectious material The wound dressing kits, bacteria filter, suction tubing, drainage tubing, and disposable carister are not included in the Forvou NPWT device package.
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