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510(k) Data Aggregation

    K Number
    K181929
    Device Name
    MiMo(TM) Negative Pressure Wound Therapy System
    Date Cleared
    2019-03-27

    (252 days)

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

    Baymax Research, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MiMo™ Negative Pressure Wound Therapy System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of low to moderate exudates 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 MiMo™ Negative Pressure Wound Therapy System is a single patient use device.
    Device Description
    The MiMo™ Negative Pressure Wound Therapy System is a portable, battery powered wound suction pump with the intention to deliver negative pressure to the wound. It consists of an electric diaphragm vacuum pump and the output pressure is regulated by a pressure sensor that reads the pressure from the wound site via connecting to the dressing. The system comes with 2 sets of silicone wound dressings. When the pump is turned on, the user will have a choice to either use 75mmHq suction or 125mmHq suction. The user will also have a choice to choose either a continuous therapy or an intermittent therapy. The MiMo™ Negative Pressure Wound Therapy System is intended for use in the professional healthcare environment. The device is powered by 4 x AAA batteries that would be able to last the user over 48 hours of usage depending upon leak rate. The batteries can be replaced if required. The pump is programmed to stop working after 168 hours (7 days) of use and will not re-start after this time, even with a new set of batteries. There will be no negative pressure at this point. The MiMo™ Negative Pressure Wound Therapy System does come with a carry bag as well as a leg strap for convenience use for the patient.
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