BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

    BIOBANDS

    K Number: K051397 · Decision Sep 16, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    12
    Applicant Total
    1
    Review Days
    112

    Basic Information

    Device Name
    BIOBANDS
    K Number
    K051397
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BIOBANDS DISTRIBUTORS, INC.
    Date Received
    May 27, 2005
    Decision Date
    September 16, 2005
    Product Code
    MVV
    Advisory Committee
    Unknown
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MVV Device, Acupressure

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MVV), ordered by most recent decision date.

    FridaMom Anti-Nausea Bands

    FDA 510(k)
    FDA Unclassified ·Unknown

    Bonine Acupressure Bands

    FDA 510(k)
    FDA Unclassified ·Unknown

    TumEase Acupressure Bracelets

    FDA 510(k)
    FDA Unclassified ·Unknown

    Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist Strip

    FDA 510(k)
    FDA Unclassified ·Unknown

    BARF BAND

    FDA 510(k)
    FDA Unclassified ·Unknown

    PRESSURE RIGHT, SINGLE-USE, DISPOSABLE, PRESSURE-SENSITIVE EMETIC-MANAGEMENT WRIST STRIP

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all