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

    ACU-STRAP MOTION SICKNESS BAND

    K Number: K041877 · Decision Oct 8, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    12
    Applicant Total
    1
    Review Days
    88

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    Basic Information

    Device Name
    ACU-STRAP MOTION SICKNESS BAND
    K Number
    K041877
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Health Ent., Inc.
    Date Received
    July 12, 2004
    Decision Date
    October 8, 2004
    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

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