BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    BCS NO. 1, BODY CARE SYSTEM

    K Number: K881800 · Decision Nov 16, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    259
    Registration Numbers
    259
    Same Product Code
    41
    Applicant Total
    1
    Review Days
    203

    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
    BCS NO. 1, BODY CARE SYSTEM
    K Number
    K881800
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5740
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    M & A Vertrieb, Liske Und Methling GM
    Date Received
    April 27, 1988
    Decision Date
    November 16, 1988
    Product Code
    IRT
    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
    IRT Pad, Heating, Powered

    Similar 510(k) Clearances

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

    bite away two

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    bite away neo

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Bite Away

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Heated Eye Pad

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    AVACEN 100

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    FIR HEAT THERAPHY SYSYEMS

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