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

    MUSCLE STIMULATOR X-10

    K Number: K840724 · Decision Mar 5, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    547
    Applicant Total
    5
    Review Days
    13

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    Basic Information

    Device Name
    MUSCLE STIMULATOR X-10
    K Number
    K840724
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Biostim, Inc.
    Date Received
    February 21, 1984
    Decision Date
    March 5, 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 Biostim, Inc.

    K Number Device Name
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    K820678 SYSTEM 10
    K802227 ANASTIM II TRANSCUTANEOUS ELECTRICAL