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

    Pulsed electromagnetic field wrap

    K Number: K202337 · Decision Dec 15, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    14
    Applicant Total
    6
    Review Days
    120

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    Basic Information

    Device Name
    Pulsed electromagnetic field wrap
    K Number
    K202337
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5290
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Hi-Dow International, Inc.
    Date Received
    August 17, 2020
    Decision Date
    December 15, 2020
    Product Code
    ILX
    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
    ILX Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat

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