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510(k) Data Aggregation

    K Number
    K983907
    Device Name
    RELIEFBAND NST DEVICE MODELS WB-2,WB-6,WB-R
    Manufacturer
    WOODSIDE BIOMEDICAL, INC.
    Date Cleared
    1999-12-09

    (401 days)

    Product Code
    GZJ
    Regulation Number
    882.5890
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    RELIEFBAND NST DEVICE MODELS WB-2,WB-6,WB-R

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

    The ReliefBand® NST™ Device is indicated for use in the treatment of nausea and vomiting (NV) due to chemotherapy, motion sickness, and pregnancy. The ReliefBand® NST™ Device is indicated as an adjunct to antiemetics in reducing postoperative nausea (PON).

    Device Description

    ReliefBand® NST™ Device Models WB-2, WB-6, and WB-R

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the Relief Band® NST™ Device. This document does not contain information regarding acceptance criteria, device performance, or study details such as sample sizes, ground truth establishment, or expert qualifications. It only states that the device is "substantially equivalent" to legally marketed predicate devices and outlines its indications for use.

    Therefore, I cannot provide the requested information based on the given text. A 510(k) summary or the full 510(k) submission would be needed to extract these details.

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