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

    sam X1 Long Duration Ultrasound Device

    K Number: K211513 · Decision Aug 18, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    8
    Applicant Total
    5
    Review Days
    96

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    Basic Information

    Device Name
    sam X1 Long Duration Ultrasound Device
    K Number
    K211513
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    890.5300
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ZetrOZ Systems, LLC
    Date Received
    May 14, 2021
    Decision Date
    August 18, 2021
    Product Code
    PFW
    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
    PFW Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat

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    Other Clearances by ZetrOZ Systems, LLC

    K Number Device Name
    K260076 SAM 3.0 Multi-Hour Continuous Ultrasound Device
    K233210 sam CS Long Duration Ultrasound Device
    K223019 sam 2.0 Long Ultrasound Device
    K191568 sam 2.0 Long Duration Ultrasound System