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510(k) Data Aggregation

    K Number
    K982967
    Device Name
    RELIEFBAND MST DEVICE, MODELS RB-2, RB-6, RB-R
    Manufacturer
    WOODSIDE BIOMEDICAL, INC.
    Date Cleared
    1999-02-23

    (182 days)

    Product Code
    GZJ
    Regulation Number
    882.5890
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    K020180,K033268
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ReliefBand® Device is indicated for the relief of nausea and vomiting (NV) due to motion sickness

    Device Description

    ReliefBand® Device Models RB-2, RB-6, and RB-R

    AI/ML Overview

    This document is a marketing clearance letter for the ReliefBand device, not a study describing acceptance criteria and device performance. Therefore, I cannot provide the requested information. The letter confirms that the device is substantially equivalent to legally marketed predicate devices for the indicated use of relieving nausea and vomiting due to motion sickness.

    To answer your request, I would need a different type of document, such as a clinical study report or a summary of safety and effectiveness data.

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