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

    E65 35 PRONE STANDER

    K Number: K892700 · Decision May 9, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    34
    Applicant Total
    7
    Review Days
    26

    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
    E65 35 PRONE STANDER
    K Number
    K892700
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3750
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Rifton Equipment For the Handicapped
    Date Received
    April 13, 1989
    Decision Date
    May 9, 1989
    Product Code
    INW
    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
    INW Table, Mechanical

    Similar 510(k) Clearances

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

    JAMES LECKEY PRONE STANDER

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    JAMES LECKEY FREE STANDER

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    EURO TECH MARQUISE CHIROPRACTIC TABLE

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    EURO TECH PLATINUM CHIROPRACTIC TABLE

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    TUMBLE FORMS JUNIOR TRISTANDER

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    PROFESSIONAL & ECONMY TILT TABLE 9500 9520

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

    Other Clearances by Rifton Equipment For the Handicapped

    K Number Device Name
    K921894 RIFTON MOBILE PRONE STANDERS
    K921817 RIFTON MOR219 19 & RIFTON MOR225 25
    K921272 ACTIVITY CHAIR
    K892697 E653 OBLONG ABDUCTION BLOCK
    K892698 E655 ADJUSTABLE ABDUCTION BLOCK W/HIP STABILIZER
    K892699 E613 PAIR OF SUPPORT BLOCKS