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510(k) Data Aggregation

    K Number
    K994109
    Device Name
    DETRUSAN 500
    Manufacturer
    INNOVAMED USA, INC.
    Date Cleared
    2000-08-03

    (241 days)

    Product Code
    KPI
    Regulation Number
    876.5320
    Why did this record match?
    Applicant Name (Manufacturer) :

    INNOVAMED USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Detrusan 500 Incontinence Treatment System is indicated for acute, ongoing or chronic treatment of Urge. Stress, or Mixed Urinary Incontinence. The System is indicated to improve urethral sphincter closure, strengthen of the pelvic floor and inhibition of the detruser muscle through reflexive mechanisms.
    Device Description
    Detrusan 500 incontinence Therapy system comes with the external electric stimulator unit and vaginal and anal electrodes (Probes made by "Laborie Medical Technologies") Vaginal Probes K 990041 Anal Probes K 993721 Approved by FDA. Detrusan 500 is a Main net powered electrical stimulator, which provides output stimulus to the probes. The Device can be adjusted to deliver AC voltages in the range up to 30 Volts. The current is depended on the resistor of the patient as standard measuring level at 500 Ohm- 60 mA limited by hardware and software up to 80 mA. Frequencies are adjustable 1 to 100 Hz The pulse width is adjustable 10 to 400 us. 12 preprogrammed follow-ups and frequencies as well as pulse width adjustments are available by calling program number. The Device is constant Voltage stabilized.
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