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510(k) Data Aggregation

    K Number
    K253305

    Validate with FDA (Live)

    Device Name
    TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)
    Manufacturer
    Shenzhen Jiantuo Electronics Co., Ltd.
    Date Cleared
    2025-12-31

    (93 days)

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

    TENS (Transcutaneous Electric Nerve Stimulation):
    To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, abdomen, bottom, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

    EMS(Electrical Muscle Stimulation):
    It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

    Device Description

    Not Found

    AI/ML Overview

    N/A

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