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

    ParaMotion

    K Number: K203761 · Decision Jan 21, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    65
    Applicant Total
    1
    Review Days
    394

    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
    ParaMotion
    K Number
    K203761
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3900
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Powerbasetec GmbH
    Date Received
    December 23, 2020
    Decision Date
    January 21, 2022
    Product Code
    IPL
    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
    IPL Wheelchair, Standup

    Similar 510(k) Clearances

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

    Walking rehabilitation training electric wheelchair (ZW518)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Action Trackchair Hawk

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Explorer Mini

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    F5 Corpus VS

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    UPnRIDE

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