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510(k) Data Aggregation

    K Number
    K200223
    Device Name
    PocketDoc™ Micro Wound Therapy System
    Date Cleared
    2020-10-23

    (268 days)

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

    Pensar Medical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    PocketDoc Micro Wound Therapy System is indicated for patients who may benefit from a suction device as it may promote wound healing through the removal of low to moderate levels of exudate and infectious material. Appropriate wound types include: - · Chronic - Acute - · Traumatic - Subacute and dehisced wounds - · Partial-thickness burns - · Ulcers (such as diabetic or pressure) - · Flaps and grafts - · Closed surgical incisions PocketDoc Micro Wound Therapy System is suitable for use in both a healthcare and homecare setting.
    Device Description
    The PocketDoc" Micro Wound Therapy System (PocketDoc) is a negative pressure wound therapy (NPWT) system that is specifically designed for shallow wounds with low to moderate amounts of exudate (*10 ml/day) that no longer or never required a collection canister. The system consists of a disposable, small, lightweight, battery operated, portable suction device (pump control unit) containing an electric motor driven vacuum pump, Enluxtra Humifiber Wound Dressings made of a hydrophilic gelling fiber (K122297), adhesive polyurethane drapes and StingRay TPE flanges with PVC tubing to connect the dressing/drape to the suction device. The dressing is applied over the wound and the drape is applied over the dressing to hold it in place. The flange on top of the drape is connected to the pump control unit via the tubing. The dressings, drapes, flanges and tubing are supplied sterile and are for single use. The pump control unit is for single patient use and is provided nonsterile. The PocketDoc" Micro Wound Therapy System is suitable for use in both a healthcare and homecare setting. The portable suction device can be placed in a pocket, a carrier or attached to the body with an arm/leg Velcro strap which is provided.
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