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510(k) Data Aggregation

    K Number
    K130951
    Device Name
    SIM
    Manufacturer
    SIMAVITA PTY LIMITED
    Date Cleared
    2013-08-22

    (139 days)

    Product Code
    KPN
    Regulation Number
    876.2040
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SIM™ (Smart Incontinence Management) is indicated for use by healthcare professionals to remotely monitor wetness events, and collect, transmit and report wetness events and other medical information from multiple patients within a clinical setting (e.g., hospitals, skilled nursing facilities, residential care facilities), to establish effective management care plans for continence events.
    Device Description
    SIM™ consists of disposable incontinence pads with embedded sensors, a wireless transceiver, hardware, and software.
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    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
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    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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    K Number
    K971855
    Device Name
    POTTY PAL AND FOREVER-DRY
    Manufacturer
    DIGITAL APPLICATIONS, INC.
    Date Cleared
    1997-08-18

    (90 days)

    Product Code
    KPN
    Regulation Number
    876.2040
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Potty Pal: This device is indicated as a daytime enuresis alarm that may be used by a parent or caregiver to assist toddlers in toilet training. Forevery Dry: This device is indicated as nighttime enuresis alarm to aid in solving a child's nighttime bedwetting problem.
    Device Description
    The Forever Dry and Potty Pal consist of: Training parts, which has sewn in mylas conductive strips. The strips are connected to an audible alarm. Powered by a 9V battery
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