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510(k) Data Aggregation

    K Number
    K142369
    Device Name
    Urinary Incontinence System
    Date Cleared
    2015-06-17

    (296 days)

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

    GUANGZHOU FINECURE MEDICAL EQUIPMENT CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Urinary Incontinence System with various treatment modalities is intended to be used by males and females for muscle contraction in the treatment of stress incontinence, urge incontinence, and mixed incontinence.
    Device Description
    The Finecure Urinary Incontinence System is a non-implanted, electrical, pelvic floor muscle stimulator. It is intended to strengthen the pelvic floor muscles by electrical stimulation in the treatment for urinary incontinence. The system has several preset modes that correspond to different conditions associated with urinary incontinence. The Urinary Incontinence System can be used in the clinical setting and the home care environment. The System is composed of enclosure, display screen, PCB, rotary switch, and other electronic components. The system is to be used with pelvic floor probes and anorectal probes.
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    K Number
    K140265
    Device Name
    ELECTRODE FOR URINARY INCONTINENCE
    Date Cleared
    2015-01-23

    (354 days)

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

    GUANGZHOU FINECURE MEDICAL EQUIPMENT CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Urinary Incontinence Probe, model PR-51 Vaginal Probe are intended to provide electromyographic feedback from pelvic musculature or electrical stimulation for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence. The Urinary Incontinence Probe, model PR-51 Vaginal Probe & PR-52 Anal Probe are intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.
    Device Description
    The Urinary Incontinence Probe, model PR-51 Vaginal Probe & PR-52 Anal Probe are the light weight cylinder consisting of two independent conductive rings that are paired and isolated, physically and electrically. The cylinder is shaped with a handle for comfort positioning in vaginal/anal canal for incontinent treatment as above mentioned and easy for removing after treatment. It is watertight to allow for washing with soap and water between uses. The probe is designed for repeated intermittent use in home or clinic for up to one year by a single user. It does not require sterilization, but does required washing for reuse according to the validated cleaning method as recommended in user manual. To fit with different type of device connection, the lead wire of device was provided with three different type of wire connection terminals, 2mm pigtail, 3.5mm femelle and 2.35 mm femelle. Either of the PR-51 Vaginal Probe & PR-52 Anal Probe can be connected to any one of three connection terminals.
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