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510(k) Data Aggregation

    K Number
    K031310
    Device Name
    TAI SHENG VARIOUS NEOX POWERED MUSCLE STIMULATOR
    Manufacturer
    TAI SHENG ELECTRICAL MACHINERY CO., LTD.
    Date Cleared
    2004-04-12

    (354 days)

    Product Code
    IPF
    Regulation Number
    890.5850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    K062453
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Specific indications: used to apply an electrical current to electrodes on pation's skin to function as: Relaxation of muscle spasms; Clinical settings: The device should only be used under medical supervisions for adjunctive therapy for the treatment of medical discases and conditions.

    Device Description

    TAI SHENG Powered Muscle Stimulator, TS-L166

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance tables, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, type of ground truth used, or information about the training set.

    The document is a letter from the FDA concerning a 510(k) premarket notification for the "TAI SHENG Powered Muscle Stimulator, TS-L166." It primarily states that the device has been determined to be substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements the manufacturer must follow. The "Indications for Use Statement" lists the intended purposes of the device, but it does not contain any performance data or study details.

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