LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K041766
    Device Name
    EZY-TRAVEL WRISTBAND
    Manufacturer
    APOTHECARY PRODUCTS, INC.
    Date Cleared
    2004-11-26

    (149 days)

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

    EZY-TRAVEL WRISTBAND

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

    For the relief of nausea. Nausea may be caused by motion, morning sickness, chemotherapy or anesthesia.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for the "Ezy-Travel Wristbands," an acupressure device. This letter indicates a finding of substantial equivalence to a legally marketed predicate device for the stated indications for use (relief of nausea).

    However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for the device. The letter solely states that the device is substantially equivalent and can be marketed.

    Therefore, I cannot provide the requested information from the given text. The document does not describe the acceptance criteria or a study that proves the device meets them.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1