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

    HEALTHTRONIC OMEGA TRAC

    K Number: K881902 · Decision Jun 22, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    65
    Applicant Total
    2
    Review Days
    47

    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
    HEALTHTRONIC OMEGA TRAC
    K Number
    K881902
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5880
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Healthtronics Surgical Services, Inc.
    Date Received
    May 6, 1988
    Decision Date
    June 22, 1988
    Product Code
    JFB
    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
    JFB Table, Physical Therapy, Multi Function

    Similar 510(k) Clearances

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

    Ceragem Automatic Thermal Massager (CGM MB-2401)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Ceragem Automatic Thermal Massager (CGM-MB-1902)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    N7-S

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702

    FDA 510(k)
    FDA Class 2 ·Physical Medicine
    View all

    Other Clearances by Healthtronics Surgical Services, Inc.

    K Number Device Name
    K012785 TWINTRODE ELC 134 ELECTRODE