LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    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
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Tyece OTC EMS System, Model EM35

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a powered muscle stimulator. It does not contain information about acceptance criteria, study details, or device performance as typically found in a clinical study report or a detailed summary of safety and effectiveness. Therefore, I cannot extract the requested information to fill in the table or answer the specific questions about a study proving device performance.

    The document primarily states that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls provisions of the Act. It also includes the indications for use for the device.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1