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510(k) Data Aggregation

    K Number
    K961050
    Device Name
    RELIEFBAND TENS UNIT (MODIFICATION)
    Manufacturer
    MAVEN LABS, INC.
    Date Cleared
    1997-08-01

    (540 days)

    Product Code
    GZJ,73B
    Regulation Number
    882.5890
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    K980333
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To reduce the frequency of nausea and vomiting due to chemotherapy, motion sickness, and pregnancy.

    Device Description

    Not Found

    AI/ML Overview

    The provided document does not contain any information regarding acceptance criteria, device performance studies, or clinical trial data.

    The document is a 510(k) clearance letter from the FDA for a device named "ReliefBand." This letter states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot fulfill your request for information about acceptance criteria, study details, or performance metrics from this document. This kind of information would typically be found in the 510(k) submission itself or in published clinical studies related to the device, not in the FDA clearance letter.

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