BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MUSCLE TESTING GUN

    K Number: K791021 · Decision Jun 15, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    11
    Applicant Total
    1
    Review Days
    16

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    Basic Information

    Device Name
    MUSCLE TESTING GUN
    K Number
    K791021
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.1250
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Applicant
    The Orthodyn Co.
    Date Received
    May 30, 1979
    Decision Date
    June 15, 1979
    Product Code
    HRW
    Advisory Committee
    Orthopedic
    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
    HRW Dynamometer, Nonpowered

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