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510(k) Data Aggregation

    K Number
    K191938
    Device Name
    FitRelief TENS&EMS Wireless Device
    Manufacturer
    Heat In A Click LLC.
    Date Cleared
    2020-08-28

    (406 days)

    Product Code
    NGX,NUH
    Regulation Number
    890.5850
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FitRelief TENS&EMS Wireless Device

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

    Not Found

    Device Description

    Not Found

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for the "FitRelief TENS&EMS Wireless Device." This document confirms that the device has been found substantially equivalent to legally marketed predicate devices.

    However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

    Therefore, I cannot provide the requested information based on the content of this document.

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