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510(k) Data Aggregation

    K Number
    K002329
    Device Name
    PELVX GELLHORN VAGINAL PESSARY 603-608
    Manufacturer
    DESCHUTES MEDICAL PRODUCTS, INC.
    Date Cleared
    2000-09-18

    (48 days)

    Product Code
    HHW
    Regulation Number
    884.3575
    Why did this record match?
    Applicant Name (Manufacturer) :

    DESCHUTES MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K994079
    Device Name
    REFLEX TREATMENT SYSTEM
    Manufacturer
    DESCHUTES MEDICAL PRODUCTS, INC.
    Date Cleared
    2000-03-01

    (90 days)

    Product Code
    HIR, 85H
    Regulation Number
    884.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    DESCHUTES MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ReFlex Treatment System is intended for the treatment of stress incontinence and/or urge incontinence in females.
    Device Description
    The ReFlex Treatment System is a comprehensive, behavioraliy-based program designed for independent use by incontinent people in their own home. The product kit includes a personal training device, an informational video, instructional journal, and direct clinical support via phone and internet. At the program's core is the pneumatically-based ReFlex Trainer, a handheld device which when connected to the vaginal sensor displays the magnitude of pelvic muscle contractions.
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    K Number
    K990593
    Device Name
    PELVX INCONTINENCE DISH, MODEL 301-306
    Manufacturer
    DESCHUTES MEDICAL PRODUCTS, INC.
    Date Cleared
    1999-05-24

    (89 days)

    Product Code
    HHW, 85H
    Regulation Number
    884.3575
    Why did this record match?
    Applicant Name (Manufacturer) :

    DESCHUTES MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PelvX Incontinence Dish Vaginal Pessary is intended for treatment of stress urinary incontinence combined with a mild 1st or 2nd degree uterine prolapse and/or a mild cystocele.
    Device Description
    The PelvX Incontinence Dish Vaginal Pessary is a pessary intended for the treatment of stress urinary incontinence. It is made of medical grade silicone and is shaped like a dish to surround and support the cervical area and bladder areas. Holes in the dish allow drainage of vaginal fluids. It features a bulbous portion at one location on its circumference designed to support and elevate the bladder neck, thereby providing improved urethral sphincter control.
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    K Number
    K974115
    Device Name
    PELVX RING, PELVX RING WITH SUPPORT
    Manufacturer
    DESCHUTES MEDICAL PRODUCTS, INC.
    Date Cleared
    1998-04-27

    (178 days)

    Product Code
    HHW
    Regulation Number
    884.3575
    Why did this record match?
    Applicant Name (Manufacturer) :

    DESCHUTES MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PelvX Ring Vaginal Pessary is a vaginal pessary intended for support of 1st and 2nd degree prolapse. The PelvX Ring with Support Vaginal Pessary is a vaginal pessary intended for support of 1st and 2nd degree prolapse combined with mild cystocele.
    Device Description
    Not Found
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    K Number
    K974116
    Device Name
    PELVX INCONTINENCE RING
    Manufacturer
    DESCHUTES MEDICAL PRODUCTS, INC.
    Date Cleared
    1998-04-27

    (178 days)

    Product Code
    HHW
    Regulation Number
    884.3575
    Why did this record match?
    Applicant Name (Manufacturer) :

    DESCHUTES MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PelvX Incontinence Ring Vaginal Pessary is a vaginal pessary intended for treatment of of a sourinary incontinence.
    Device Description
    PelvX Incontinence Ring Vaginal Pessary
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    K Number
    K974117
    Device Name
    PELVX DONUT, PELVX CUBE
    Manufacturer
    DESCHUTES MEDICAL PRODUCTS, INC.
    Date Cleared
    1998-04-27

    (178 days)

    Product Code
    HHW
    Regulation Number
    884.3575
    Why did this record match?
    Applicant Name (Manufacturer) :

    DESCHUTES MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PelvX Donut Vaginal Pessary is a vaginal pessary intended for support of 310 degree prolapse. The PelvX Cube Vaginal Pessary is a vaginal pessary intended for support of 314 degree prolapse combined with rectocele and/or cystocele.
    Device Description
    Not Found
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