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510(k) Data Aggregation

    K Number
    K233492
    Device Name
    EMS Neck Massager
    Manufacturer
    Xiamen Comfier Technology Co., Ltd
    Date Cleared
    2023-12-20

    (51 days)

    Product Code
    NGX
    Regulation Number
    890.5850
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The EMS Neck Massager is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.

    Device Description

    Not Found

    AI/ML Overview

    I'm sorry, but this document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria.

    The provided text is an FDA 510(k) clearance letter for an "EMS Neck Massager." This type of letter confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It lists the regulation, product code, and indications for use.

    However, it does not include:

    • A table of acceptance criteria and reported device performance.
    • Details about sample size, data provenance, expert qualifications, or adjudication methods for a test set.
    • Information about multi-reader multi-case studies or effect sizes.
    • Results from standalone algorithm performance.
    • Details about the type of ground truth used or the training set size/ground truth establishment.

    This document is a regulatory communication, not a performance study report.

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