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510(k) Data Aggregation

    K Number
    K162610
    Device Name
    NEXA Negative Pressure Wound Therapy System
    Manufacturer
    Date Cleared
    2017-06-08

    (262 days)

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

    Nexa Medical Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NEXA NPWT system is intended for patients who may benefit from the application of negative pressure to the wound to promote wound healing through the removal of excess exudate, infectious material and tissue debris. It is intended for use in long-term care and acute settings only when prescribed by a Health Care Professional. Appropriate wound types include: - Chronic wounds - · Pressure ulcers - · Diabetic foot ulcers - · Venous leg ulcers
    Device Description
    The NEXA NPWT System is an integrated negative pressure wound management system for use in acute and extended care settings. The system applies a negative pressure to a sealed wound dressing and promotes wound healing through the removal of exudates into a disposable fluid container. The system consists of the following key components: - NEXA Device: A portable device that contains a pump and a rechargeable Battery and is supplied with a Power Supply and a Carry Case. - NEXA Fluid Container Pack: A single use polymeric flexible fluid container that stores the exudate removed from the wound. - NEXA Dressing: Sterile single use wound dressing components that are in contact with the wound tissue and a means of sealing to the periwound area. Interconnect tubing includes an integrated negative pressure relief valve that limits the maximum pressure able to be applied to the wound and are pre-set and not adjustable by the user.
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