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

    WORK SIMULATOR

    K Number: K800007 · Decision Jan 21, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    159
    Applicant Total
    7
    Review Days
    18

    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
    WORK SIMULATOR
    K Number
    K800007
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5380
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Baltimore Therapeutic Equipment Co.
    Date Received
    January 3, 1980
    Decision Date
    January 21, 1980
    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 Baltimore Therapeutic Equipment Co.

    K Number Device Name
    K955106 BTE CPM-20
    K955105 BTE CPM-10
    K925225 THE BTE VECTOR; ANALYSIS SYSTEM FOR THE LOW BACK
    K933611 THE BTE WS30
    K924414 THE BTE DYNAMIC LIFT
    K895881 MOTIONSPECT