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    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    APEX MEDICAL DIGITAL EMS TS1311, TS1312

    K Number: K021754 · Decision Jun 28, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    547
    Applicant Total
    30
    Review Days
    30

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    Basic Information

    Device Name
    APEX MEDICAL DIGITAL EMS TS1311, TS1312
    K Number
    K021754
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Apex Medical Corp.
    Date Received
    May 29, 2002
    Decision Date
    June 28, 2002
    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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