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

    PORTABLE ISOKINETICS 3007 BACK/ABDOMEN UNIT

    K Number: K862998 · Decision Aug 20, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    60
    Applicant Total
    6
    Review Days
    12

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    Basic Information

    Device Name
    PORTABLE ISOKINETICS 3007 BACK/ABDOMEN UNIT
    K Number
    K862998
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.1925
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Kent Design & Manufacturing, Inc.
    Date Received
    August 8, 1986
    Decision Date
    August 20, 1986
    Product Code
    IKK
    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
    IKK System, Isokinetic Testing And Evaluation

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    Other Clearances by Kent Design & Manufacturing, Inc.

    K Number Device Name
    K862995 PORTABLE ISOKINETICS 3003 SHOULDER UNIT
    K862993 PORTABLE ISOKINETICS 3001 WRIST/ANKLE UNIT
    K862997 PORTABLE ISOKINETICS 3005 HIP UNIT
    K862994 PORTABLE ISOKINETICS 3002 ISO KANE II
    K862996 PORTABLE ISOKINETICS 3004 KNEE UNIT