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510(k) Data Aggregation

    K Number
    K202317
    Device Name
    Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806
    Manufacturer
    Everyway Medical Instruments Co., Ltd.
    Date Cleared
    2020-11-13

    (88 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: intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. (For EV-806: Choose TENS Modes B/N/M/SD1/SD2 adjustable mode).

    EMS: intended to stimulate healthy muscles in order to improve or facilitate muscle performance. (For EV-806 : Choose EMS Modes C/S/A adjustable mode)

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a Transcutaneous Electrical Nerve Stimulator (TENS)/Electrical Muscle Stimulator (EMS) device. It confirms that the device is substantially equivalent to legally marketed predicate devices.

    However, the provided document does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria. The letter focuses on the regulatory clearance process and substantial equivalence, not on the technical performance evaluation of the device in the context of specific performance metrics or clinical study results.

    Therefore, I cannot provide details for the following points based on the given input:

    1. A table of acceptance criteria and the reported device performance
    2. Sample size used for the test set and the data provenance
    3. Number of experts used to establish the ground truth for the test set and their qualifications
    4. Adjudication method for the test set
    5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done
    6. If a standalone (algorithm only without human-in-the-loop performance) study was done
    7. The type of ground truth used
    8. The sample size for the training set
    9. How the ground truth for the training set was established

    The letter indicates that the device is intended for "temporary relief of pain associated with sore and aching muscles" (TENS) and "to stimulate healthy muscles in order to improve or facilitate muscle performance" (EMS). While these are the intended uses, there are no performance metrics or study details within this document to evaluate how well the device achieves these indications.

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