BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM

    K Number: K121059 · Decision Aug 7, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    54
    Applicant Total
    2
    Review Days
    123

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM
    K Number
    K121059
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    890.5860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zimmer Medizinsystems GmbH
    Date Received
    April 6, 2012
    Decision Date
    August 7, 2012
    Product Code
    IMG
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IMG Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (IMG), ordered by most recent decision date.

    Ultrasound Therapy Workstation (XMS-UET2)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ComboRehab

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    BTL-4000

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SONICSTIMU COMBO THERAPEUTIC DEVICE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    FUTURA

    FDA 510(k)
    FDA Class 2 ·Physical Medicine
    View all

    Other Clearances by Zimmer Medizinsystems GmbH

    K Number Device Name
    K141564 OPTON PRO