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510(k) Data Aggregation

    K Number
    K183454
    Device Name
    Tyece OTC EMS System
    Manufacturer
    Tyece Ltd.
    Date Cleared
    2019-02-26

    (75 days)

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

    Tyece Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tyece OTC EMS System, Model EM37 is intended for use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance.
    Device Description
    Not Found
    Ask a Question
    K Number
    K172241
    Device Name
    Tyece OTC EMS System, Model EM35
    Manufacturer
    Tyece Ltd.
    Date Cleared
    2017-11-20

    (117 days)

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

    Tyece Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tyece OTC EMS System, Model EM35 is intended for use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance.
    Device Description
    Not Found
    Ask a Question

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