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

    ProMedTek Model C1400 Shortwave Diathermy Device

    K Number: K162240 · Decision Nov 17, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    44
    Applicant Total
    2
    Review Days
    100

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    Basic Information

    Device Name
    ProMedTek Model C1400 Shortwave Diathermy Device
    K Number
    K162240
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5290
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Promedtek, Inc.
    Date Received
    August 9, 2016
    Decision Date
    November 17, 2016
    Product Code
    IMJ
    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
    IMJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat

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    Other Clearances by Promedtek, Inc.

    K Number Device Name
    K070931 MODEL PMT850