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

    BIODEX SYSTEM 2,MODEL S2-S

    K Number: K913020 · Decision Oct 3, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    60
    Applicant Total
    7
    Review Days
    86

    Basic Information

    Device Name
    BIODEX SYSTEM 2,MODEL S2-S
    K Number
    K913020
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.1925
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Biodex Corp.
    Date Received
    July 9, 1991
    Decision Date
    October 3, 1991
    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

    Similar 510(k) Clearances

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

    AMES THERAPY DEVICE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    HUMAC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    CC RIDER, MODEL ME180

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    CYBEX 770

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    MOTIVATOR FTR 2000

    FDA 510(k)
    FDA Class 2 ·Physical Medicine
    View all

    Other Clearances by Biodex Corp.

    K Number Device Name
    K915846 BIODEX SYSTEM 2 AUTOPROGRAM
    K915648 BIODEX SYSTEM 2 AUTOPROGRAM
    K913021 BIODEX,MODEL B-2000
    K900450 BIODEX LIFT SIMULATOR
    K900741 BIODEX BACK SYSTEM ATTACHMENT
    K860821 BIODEX SYSTEM