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

    Therm-X

    K Number: K193550 · Decision Feb 28, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    95
    Registration Numbers
    95
    Same Product Code
    152
    Applicant Total
    5
    Review Days
    70

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    Basic Information

    Device Name
    Therm-X
    K Number
    K193550
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5650
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zenith Technical Innovations
    Date Received
    December 20, 2019
    Decision Date
    February 28, 2020
    Product Code
    IRP
    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
    IRP Massager, Powered Inflatable Tube

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    Other Clearances by Zenith Technical Innovations

    K Number Device Name
    K240125 Therm-X (Home); Therm-X (AT)
    K231912 Therm-X
    K190854 Therm-X
    K181149 Therm-X Pro, Therm-X AT, Therm-X Pro Athlete