BEUDAMED
    Product Code: IOE FDA class 1 21 CFR 890.5370

    Bars, Parallel, Exercise

    Physical Medicine

    Parallel Exercise Bars are Physical Medicine rehabilitation devices consisting of two horizontal parallel rails set at adjustable heights, used to support patients during ambulation training, balance exercises, and gait rehabilitation following injury, surgery, or neurological impairment. It is classified as FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. The product code is IOE, regulated under 21 CFR 890.5370, within the Physical Medicine medical specialty. This device is GMP exempt, indicating it is not subject to full good manufacturing practice requirements.

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    510(k)s
    2
    FEI Numbers
    16
    Registration Numbers
    16
    Unique Applicants
    2
    Years Active
    6

    Basic Information

    Product Code
    IOE
    Device Class
    FDA class 1
    Regulation Number
    890.5370
    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 2 510(k) clearances via K numbers.

    K Number Device Name
    K830466 BARS, PARALLEL, EXERCISE
    K770611 PARALLEL BARS

    FEI Numbers

    This FDA classification entry is associated with 16 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 16 registration numbers. Click on an entry to view related FDA registrations.