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    K Number
    K162689
    Device Name
    Vibrance Pelvic Trainer
    Manufacturer
    BIOINFINITY (M) SDN. BHD.
    Date Cleared
    2017-06-08

    (254 days)

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

    BIOINFINITY (M) SDN. BHD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vibrance® Pelvic Trainer is intended for the strengthening of the pelvic floor muscles, which has been found to help women with urinary incontinence.
    Device Description
    The Vibrance® Pelvic Trainer is a repeat use, non-sterile intra-vaginal exercise device intended to strengthen the pelvic floor musculature by offering resistance to an individual's voluntary contractions of these muscles. The Vibrance® Pelvic Trainer incorporates an active vibration biofeedback mechanism for the identification of the pelvic floor muscles, and the sheaths provide graduated resistance levels for the progressive strengthening of the pelvic floor muscle. The device is intended for home use. The therapeutic effect is from the user using the device to exercise the pelvic floor muscles in accordance with the exercise program included in the instructions. The device provides biofeedback information that allows the user to verify the use of the correct muscles in the exercise routine and thus the effectiveness of the exercises undertaken. The device also includes a resistive component to the training program to strengthen the pelvic floor muscle via physiologic principles. The biofeedback mechanism works by directly sensing the force applied by the pelvic floor muscle. The device consists of the Main Body and three Resistance Sheaths with varying degrees of stiffness. It has a PCB assembly and is a battery-powered device (140mAh, 3.7V lithium polymer battery) with USB charging capability, operating on two independent, enclosed electronic circuits for the vibration biofeedback loop and the other for audio guided training. The maximum diameter of the Vibrance® Pelvic Trainer shaft is 2.4 cm. The maximum inserted length of the shaft is 6 cm.
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