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

    BMR POWERSTIM

    K Number: K840149 · Decision Jan 30, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    547
    Applicant Total
    5
    Review Days
    17

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    Basic Information

    Device Name
    BMR POWERSTIM
    K Number
    K840149
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Bio-Medical Research Corp.
    Date Received
    January 13, 1984
    Decision Date
    January 30, 1984
    Product Code
    IPF
    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
    IPF Stimulator, Muscle, Powered

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    Other Clearances by Bio-Medical Research Corp.

    K Number Device Name
    K071666 SLENDERTONE ENERVIVE, MODEL 561
    K070142 SLENDERTONE SYSTEM ABS, MODELS 390, E10, X10; SLENDERTONE SYSTEM SHORTS, MODELS 390, E20
    K840147 BMR-2 MUSCLE STIMULATOR
    K840148 BMR-16 CLINIC MUSCLE STIMULATOR