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510(k) Data Aggregation

    K Number
    K233098
    Device Name
    MYOTouch Muscle Stimulator
    Manufacturer
    SunMed LLC.
    Date Cleared
    2024-08-02

    (311 days)

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

    SunMed LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MYOTouch Muscle Stimulator is indicated for use as an adjunct in the treatment of high and low anorectic malformations by helping with the identification of striated muscles to be used in anal reconstructions. The MYOTouch device is intended for use by trained personnel who are competent to apply the appropriate stimuli.
    Device Description
    MYOTouch is a hand-held device designed to be used for surgical correction of neonatal anorectal malformations. MYOTouch is intended for prescription use. The device is a 9V battery-powered, one-channel muscle stimulator. The device is supplied with a Sterile Stylus, which connects to the control unit by cable and plug. The MYOTouch muscle stimulator has been specially designed to meet the requirements of pediatric surgeons who need a reliable and easy to use muscle locating stimulator when carrying out the Pena, "Pull-through", or posterior sagittal anorectoplasty (PSARP) anorectal reconstruction technique. A trained professional or pediatric surgeon must use the MYOTouch device. The pediatric surgeon uses manual, push-button controls to control the electrical stimulation level. The unit is intended for prescription use and is designed with simplicity and ease of use. It has two preset modes available.
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