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

    NORELCO MASSAGER PLUS HEAT BELT

    K Number: K811891 · Decision Jul 20, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    759
    Registration Numbers
    759
    Same Product Code
    99
    Applicant Total
    15
    Review Days
    19

    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
    NORELCO MASSAGER PLUS HEAT BELT
    K Number
    K811891
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5660
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    North American Philips Corp.
    Date Received
    July 1, 1981
    Decision Date
    July 20, 1981
    Product Code
    ISA
    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
    ISA Massager, Therapeutic, Electric

    Similar 510(k) Clearances

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

    VMAT PRO

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    ShockPhysio Mobile (model SW3200 Basic)

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    BTL-094

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Omnispec ED1000

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    OW100S (model OW100S-US)

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    DolorClast Radial

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

    Other Clearances by North American Philips Corp.

    K Number Device Name
    K842486 ELECTRONIC DIGITAL BP METER HC 3001
    K841489 NORELCO ELECTRONIC DIGITAL BP METER
    K833755 ELECTRONIC DIGITAL FEVER THERMOMETER
    K830715 NORELCO VIBRATING BOARD V900
    K830685 NORELCO DELUXE DIGITAL BLOOD PRESSURE
    K830687 NORELCO ELECTRONIC ANALOG BLOOD PRESS
    K830686 ANEROID BLOOD PRESSURE CUFF #HC1400
    K830684 NORELCO ELECTRONIC DIGITAL BLOOD PRESS
    K813451 UVA FLUORESCENT TANNING LAMPS
    K811636 NORELCO ELECTRONIC BLOOD PRESSURE METER
    Search all 15 clearances from North American Philips Corp. →