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

    CLUB FOOT CPM MACHINE

    K Number: K903851 · Decision Oct 19, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    159
    Applicant Total
    87
    Review Days
    59

    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
    CLUB FOOT CPM MACHINE
    K Number
    K903851
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5380
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Smith & Nephew Richards, Inc.
    Date Received
    August 21, 1990
    Decision Date
    October 19, 1990
    Product Code
    BXB
    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
    BXB Exerciser, Powered

    Similar 510(k) Clearances

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

    G-TRAINER MEDICAL

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    FLO-BOOT

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    ANKLE CALF EXERCISER PHLEBOPUMP

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    E-Z FLEX

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    BTE CPM-20

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    BTE CPM-10

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

    Other Clearances by Smith & Nephew Richards, Inc.

    K Number Device Name
    K965224 EMPOWER ANTERIOR DIRECT SCREWS
    K963509 GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON
    K960444 FINN ROD TO ROD CONNECTOR
    K964163 TRIMAX NAIL SYSTEM
    K962557 GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENT
    K963486 REVISION HIP SYSTEM
    K962541 REFLECTION ACETABULAR REINFORCEMENT RINGS
    K962808 ILIZAROV EXTERNAL FIXATION SYSTEM
    K962137 GENESIS II CONSTRAINED SYSTEM
    K955767 COFIED MODULAR SHOULDER SYSTEM
    Search all 87 clearances from Smith & Nephew Richards, Inc. →