BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    Atalante X

    K Number: K232077 · Decision Dec 13, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    23
    Applicant Total
    3
    Review Days
    153

    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
    Atalante X
    K Number
    K232077
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3480
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wandercraft SAS
    Date Received
    July 13, 2023
    Decision Date
    December 13, 2023
    Product Code
    PHL
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PHL Powered Exoskeleton

    Similar 510(k) Clearances

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

    Atalante X

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ReWalk® 7 Personal Exoskeleton (50-20-0005)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Medical HAL Lower Limb Type (HAL-ML)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ReWalk P6.0

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Atalante

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    EksoNR

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

    Other Clearances by Wandercraft SAS

    K Number Device Name
    K250904 Atalante X
    K221859 Atalante