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510(k) Data Aggregation

    K Number
    K143031
    Device Name
    mcompass Biofeedback Anorectal Manometry System
    Manufacturer
    MEDSPIRA, LLC
    Date Cleared
    2015-07-07

    (259 days)

    Product Code
    KLA, HCC
    Regulation Number
    876.1725
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDSPIRA, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The mcompass Biofeedback Anorectal Manometry System is for use on patients requiring anorectal pressure studies and biofeedback therapy.
    Device Description
    The mcompass Biofeedback Anorectal Manometry System is a manometry system for the measurement of anorectal pressures. It provides visual feedback (biofeedback) of the muscle action allowing the patient to modulate the activity of the anorectal muscles, thereby reeducating the pelvic floor muscles. It is used in a clinical setting and consists of a non-sterile disposable catheter (2-channel or 5-channel), a previously cleared reusable RMD FOB (and related battery charger), and software that resides on a tablet PC and that collects, records and displays the pressure data. Air-charged balloons are used to measure contractile pressures of the anorectal canal and simulate a range of bowel fullness levels, in addition to measuring locational pressure at the distal tip of the catheter. During the clinical procedure, the distal end of the catheter is inserted in the anus/rectum of the patient. The proximal end of the catheter is connected via an integrated cable to the handheld RMD FOB which transmits real-time pressure data wirelessly to the mcompass software on the PC
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    K Number
    K120088
    Device Name
    MCOMPASS ANORECTAL MANOMETRY SYSTEM
    Manufacturer
    MEDSPIRA, LLC
    Date Cleared
    2012-03-29

    (78 days)

    Product Code
    KLA
    Regulation Number
    876.1725
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDSPIRA, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The mcompass Anorectal Manometry System is for use on patients requiring anorectal pressure studies.
    Device Description
    The mcompass device is a manometry system for the measurement of anorectal pressures. It is used in a clinical setting and consists of a non-sterile disposable catheter, a reusable RMD FOB, and software that resides on a tablet PC that collects, records and displays data. During the clinical procedure, the distal end of the catheter is inserted in the anus/rectum of the patient. The proximal end of the catheter is connected via an integrated cable to the handheld RMD FOB which transmits real-time pressure data wirelessly to the mcompass software on the PC. Pressures are measured via four small, air-charged, radial balloons evenly spaced around the distal circumference of the catheter and a fifth larger balloon, positioned near the distal tip. The four small balloons measure radial contractile pressures of the anorectal canal while the most distal balloon is used to simulate a range of bowel fullness levels, in addition to measuring locational pressure.
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