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510(k) Data Aggregation

    K Number
    K233070
    Device Name
    Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N)
    Manufacturer
    Chongqing Rob Linka Science And Technology Co., Ltd.
    Date Cleared
    2024-03-13

    (169 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 :

    Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SM9027 Smart Muscle Training Wearables is intended for use by healthy persons to apply transcutaneous electrical muscle stimulation (EMS) through skin contact electrodes for the following purposes: - Improvement of muscle tone of the muscles in the abdomen, arms and thighs.
    The SM9037 Smart Muscle Training Wearables is intended for use by healthy persons to apply transcutaneous electrical muscle stimulation (EMS) through skin contact electrodes for the following purposes: - Improvement of muscle tone of the muscles in the abdomen, arms and thighs.
    The SM9566 Smart Muscle Training Wearables is intended for use by healthy persons to apply transcutaneous electrical muscle stimulation (EMS) through skin contact electrodes for the following purposes: - Improvement of muscle tone of the muscles in the abdomen, arms and thighs.
    The SM9065N Smart Muscle Training Wearables is intended for use by healthy persons to apply transcutaneous electrical muscle stimulation (EMS) through skin contact electrodes for the following purposes: - Improvement of muscle tone of the muscles in the abdomen, arms and thighs.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study design, or ground truth establishment. The document is an FDA 510(k) clearance letter for Smart Muscle Training Wearable devices, outlining their indications for use and regulatory compliance. It does not include details of a clinical study or performance evaluation with specific metrics.

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