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510(k) Data Aggregation

    K Number
    K971442
    Device Name
    HUGHES BLADDER AND BOWEL TRAINING SYSTEM(AD-T-18, MED-18,MED-1,MED-T-1,MEDD-18,MED-38,MED-T-10,MED-T-25,MED-T-5
    Manufacturer
    HUMED, INC.
    Date Cleared
    1998-01-08

    (262 days)

    Product Code
    KPN
    Regulation Number
    876.2040
    Why did this record match?
    Applicant Name (Manufacturer) :

    HUMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The proposed product, Hughes Bowel and Bladder System Model MeD-18, is an enuresis alarm, a device to detect urine and/or feces and to set off a vibratory alarm when detected, that may be used by an ambulatory adult to assist in the control of incontinence. Hughes Bowel and Madder System model MeD-18 helps persons with incontinence manage of overcome bladder control problems by providing them with a private alarm system to detect when uncontrolled urination or excretion begins. Hughes Bowel and Bladder System, model MeD-18, assists in controlling incontinence so that the wearer can manage their comditon promptly and with complete discretion at the first sign of bladder or bowel release day or night.
    Device Description
    The proposed product, Hughes Bowel and Bladder System Model MeD-18, is an enuresis alarm, a device to detect urine and/or feces and to set off a vibratory alarm when detected, that may be used by an ambulatory adult to assist in the control of incontinence. The device functions with a pager-like motor that vibrates to inform the wearer of urine / feces spillage.
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