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

    GRAVITY KING (DEEMED SE 87/09/18)

    K Number: K851065 · Decision Jun 13, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    248
    Registration Numbers
    248
    Same Product Code
    42
    Applicant Total
    1
    Review Days
    90

    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
    GRAVITY KING (DEEMED SE 87/09/18)
    K Number
    K851065
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5370
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Unique Functional Products
    Date Received
    March 15, 1985
    Decision Date
    June 13, 1985
    Product Code
    ION
    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
    ION Exerciser, Non-Measuring

    Similar 510(k) Clearances

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

    ABLE-X

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    STANDEX

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    MOBILIZER

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    KNEE WALKER

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    FITNESS

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    PEDAL EXERCISER

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