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510(k) Data Aggregation

    K Number
    K211263
    Device Name
    Intrelief
    Manufacturer
    EasyMed Instruments Co., Ltd.
    Date Cleared
    2021-12-30

    (248 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

    Intrelief provides transcutaneous electrical nerve stimulation (TENS) and electrical muscle stimulation (EMS) device for the respective indications listed below.

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

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

    Device Description

    Not Found

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for the Intrelief device, indicating its substantial equivalence to predicate devices for use as a Transcutaneous Electrical Nerve Stimulator (TENS) and Electrical Muscle Stimulator (EMS) for pain relief and muscle performance, respectively.

    This document does not contain any information regarding:

    • Acceptance criteria for device performance.
    • Study details (sample size, data provenance, expert qualifications, ground truth establishment, adjudication methods, MRMC studies, standalone performance) that would prove the device meets specific performance criteria.

    Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. The FDA 510(k) clearance process primarily evaluates substantial equivalence to existing legally marketed devices, not necessarily a new clinical performance study against specific acceptance criteria for a novel technology.

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