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

    PREHENSILE HAND

    K Number: K791931 · Decision Oct 4, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    7

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    PREHENSILE HAND
    K Number
    K791931
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3420
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Therapeutic Recreation Systems, Inc.
    Date Received
    September 27, 1979
    Decision Date
    October 4, 1979
    Product Code
    IRA
    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
    IRA Hand, External Limb Component, Mechanical

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (IRA), ordered by most recent decision date.

    THE SPORTS HAND

    FDA 510(k)
    FDA Class 1 ·Physical Medicine
    View all

    Other Clearances by Therapeutic Recreation Systems, Inc.

    K Number Device Name
    K821619 THE SPORTS HAND