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

    Bonine Acupressure Bands

    K Number: K211823 · Decision Sep 1, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    12
    Applicant Total
    1
    Review Days
    79

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    Basic Information

    Device Name
    Bonine Acupressure Bands
    K Number
    K211823
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wellspring Pharmaceutical Corporation
    Date Received
    June 14, 2021
    Decision Date
    September 1, 2021
    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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