BEUDAMED
    Product Code: IRR FDA class 1 21 CFR 890.5380

    Bars, Parallel, Powered

    Physical Medicine

    Powered parallel bars are motorized rehabilitation equipment used to support patients during ambulation training and gait rehabilitation, allowing height or position adjustment to accommodate different patient needs. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is IRR, regulated under 21 CFR 890.5380, within the Physical Medicine medical specialty.

    View on FDA
    510(k)s
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    IRR
    Device Class
    FDA class 1
    Regulation Number
    890.5380
    Medical Specialty
    Physical Medicine
    Review Panel
    PM
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K932240 MODEL 5200-10,5200-12 HI-LOW ELEC. PARRALLEL BARS

    FEI Numbers

    This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.