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510(k) Data Aggregation

    K Number
    K162744
    Device Name
    Everyway OTC EMS, Model EV-805
    Date Cleared
    2017-08-03

    (307 days)

    Product Code
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    EVERYWAY MEDICAL INSTRUMENT CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Everyway OTC EMS is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The various types of muscle work that Everyway OTC EMS can impose on the stimulated muscles are able to improve or facilitate muscle performance. Everyway OTC EMS may therefore be considered a technique of muscle training.
    Device Description
    The Everyway OTC EMS, model EV-805 is a dual channel powered muscle stimulator intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The various types of muscle work that Everyway OTC EMS can impose on the stimulated muscles are able to improve or facilitate muscle performance by applying an electrical current to electrodes, which are attached on the user's skin. The device measures 101mm(H)x 68mm(W)x21.5mm(D). Its outer housing is made of injection molded thermoplastic resin with the output contact probes consist of chrome-plated spheres. The device is powered by a 9-Volt battery to generate output pulses that is discharged through the two adhesive electrode placed on the patient's skin for treatment and muscle training. The device is operated in such a way that turn on the intensity control knob and adjust the intended intensity or turn off the device during operation through the same control knob. While device is turned on for operation. User then follow the instruction for use to get appropriate stimulation treatment and/or training on the healthy muscles.
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    K Number
    K161349
    Device Name
    Everyway Incontinence Stimulation System
    Date Cleared
    2017-07-07

    (417 days)

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

    EVERYWAY MEDICAL INSTRUMENT CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Everyway Incontinence Stimulation System is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.
    Device Description
    The Everyway Incontinence Stimulation System is a dual channel powered muscle stimulator intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women. The EV-805I stimulator is basically an Everyway's existing K071951-510(K) cleared model for power muscle stimulator. To make it delivery the same stimulation output as that of chosen predicate device, we made some change in software so as to generate muscle stimulation current that is discharged through the PR-02A, PR-04A, PR-14A Life-Care Vaginal Probe on the vaginal skin for the treatment of urinary incontinence. The device is operated in such a way that turn on the intensity control knob and adjust the intended intensity or turn off the device during operation through the same control knob. While device is turned on for operation, the related LCD icons then illuminate for indicating the device is in operation condition. User then follow the instruction for use to get appropriate stimulation treatment for urinary incontinence. With the combination of the main device parts as above mentioned , the device can be used as recommended in manual for the treatment of urinary incontinence for over-the-counter (OTC) use as that of the chosen 510(K) predicate device.
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