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

    BIO-COORDINATOR SYSTEM

    K Number: K895398 · Decision Sep 28, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    60
    Applicant Total
    1
    Review Days
    21

    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
    BIO-COORDINATOR SYSTEM
    K Number
    K895398
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.1925
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Bio-Harmonizer, Inc.
    Date Received
    September 7, 1989
    Decision Date
    September 28, 1989
    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