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510(k) Data Aggregation

    K Number
    K171026
    Device Name
    Mytens Model: BW-TSX
    Manufacturer
    Bewell Connect Corp.
    Date Cleared
    2017-11-01

    (210 days)

    Product Code
    NUH,NGX
    Regulation Number
    882.5890
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.

    EMS: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.

    Device Description

    Mytens Model: BW-TSX

    AI/ML Overview

    The provided text describes an FDA 510(k) clearance letter for a device named "Mytens Model: BW-TSX". This letter confirms substantial equivalence to predicate devices and outlines the indications for use, but it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

    Therefore, I cannot provide the requested information based on the input text. The 510(k) clearance letter is a regulatory document affirming equivalence, not a detailed study report.

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