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

    DIGIT-GRIP WITH LCD (DGR002)

    K Number: K970870 · Decision May 2, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    11
    Applicant Total
    2
    Review Days
    53

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    Basic Information

    Device Name
    DIGIT-GRIP WITH LCD (DGR002)
    K Number
    K970870
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    888.1250
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Nk Biotechnical Corp.
    Date Received
    March 10, 1997
    Decision Date
    May 2, 1997
    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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    Other Clearances by Nk Biotechnical Corp.

    K Number Device Name
    K981730 DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002