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510(k) Data Aggregation

    K Number
    K142385
    Device Name
    Whisper Pump System
    Date Cleared
    2015-05-22

    (268 days)

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

    Wound RX Medical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Whisper Pump System™ is a suction device intended for aspiration of secretions and body fluids from wounds and is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing. Whisper Pump System™ is appropriate for use on the following wounds: - Pressure ulcers - Diabetic/neuropathic ulcers - Venous insufficiency ulcers - Traumatic wounds - Post-operative and dehisced surgical wounds - Explored fistulas - Skin flaps and grafts
    Device Description
    The Whisper Pump System™ is a device to remove bodily fluids for wound drainage and can be used by patients over an extended period of time as recommended by a physician. The device has a rechargeable battery and therefore is portable. A microprocessor controlled electronic battery charging unit in the suction device guarantees the safe charging of the battery, and overcharging of the battery. The Whisper Pump System™ itself is not a sterile device but can use disposable (sterile) items from other manufacturers but these items are not a part of the Whisper Pump System™, (e.g. various hose sets, containers, trocars and catheters) which have been designed for the wound drainage. The purpose of this traditional 510(k) was to modify the outer case dimensions, carrying handle ergonomics, canister bracket, and internal component reconfiguration.
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