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

    BACK MASSAGER B-400 ADJUSTABLE

    K Number: K832913 · Decision Nov 7, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    783
    Registration Numbers
    783
    Same Product Code
    99
    Applicant Total
    4
    Review Days
    70

    Basic Information

    Device Name
    BACK MASSAGER B-400 ADJUSTABLE
    K Number
    K832913
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5660
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    POLLENEX ASSOCIATED MILLS, INC.
    Date Received
    August 29, 1983
    Decision Date
    November 7, 1983
    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 POLLENEX ASSOCIATED MILLS, INC.

    K Number Device Name
    K843010 BP-800
    K843446 DIGITAL SPHYGMOMANOMETER BP-2500
    K843009 BP-1000