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

    ORTHO DX NEUROMUSCULAR STIMULATOR

    K Number: K971542 · Decision Aug 14, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    547
    Applicant Total
    4
    Review Days
    108

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    Basic Information

    Device Name
    ORTHO DX NEUROMUSCULAR STIMULATOR
    K Number
    K971542
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rehabilicare, Inc.
    Date Received
    April 28, 1997
    Decision Date
    August 14, 1997
    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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