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

    MOBILIMB HAND UNIT

    K Number: K844033 · Decision Nov 27, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    11
    Applicant Total
    6
    Review Days
    43

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    Basic Information

    Device Name
    MOBILIMB HAND UNIT
    K Number
    K844033
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5410
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Danninger Medical Technology, Inc.
    Date Received
    October 15, 1984
    Decision Date
    November 27, 1984
    Product Code
    JFA
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JFA Exerciser, Finger, Powered

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