BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    External upper limb tremor stimulator

    K Number: K182706 · Decision Oct 25, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    8
    Applicant Total
    7
    Review Days
    28

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    Basic Information

    Device Name
    External upper limb tremor stimulator
    K Number
    K182706
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.5897
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cala Health, Inc.
    Date Received
    September 27, 2018
    Decision Date
    October 25, 2018
    Product Code
    QBC
    Advisory Committee
    Neurology
    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
    QBC External Upper Limb Tremor Stimulator

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