BEUDAMED
    Product Code: IPO FDA class 3 21 CFR 890.3610

    Orthosis, Pneumatic Structure, Rigid

    Physical Medicine

    A Rigid Pneumatic Structure Orthosis is an externally applied orthotic device used in Physical Medicine that incorporates an inflatable rigid structural element to provide support, immobilization, or positional correction to a limb or body segment. Per the regulatory record, a call for Pre-Market Approval (PMA) applications to be filed by December 26, 1996, was issued under 61 FR 50711. It is classified as FDA Class 3, the highest risk category requiring a Pre-Market Approval application demonstrating safety and effectiveness before marketing. The product code is IPO, regulated under 21 CFR 890.3610, within the Physical Medicine medical specialty.

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    Basic Information

    Product Code
    IPO
    Device Class
    FDA class 3
    Regulation Number
    890.3610
    Medical Specialty
    Physical Medicine
    Review Panel
    PM
    Submission Type
    2

    Device Characteristics

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

    Definition

    Call for PMAs to be filed by 12/26/96 per 61 FR 50711 on 9/27/96