BEUDAMED
    Product Code: KNP FDA class 1 21 CFR 890.3475

    Orthosis, Corrective Shoe

    Physical Medicine

    A Corrective Shoe Orthosis is a custom or prefabricated footwear device used in physical medicine to correct or accommodate foot and lower limb deformities, redistributing plantar pressure and supporting proper alignment in patients with conditions such as flat feet, clubfoot, or leg length discrepancy. It is classified as FDA Class 1, indicating low risk subject to general controls with no premarket clearance required. The product code is KNP and it falls under 21 CFR 890.3475 in the Physical Medicine specialty. This device is GMP exempt.

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    510(k)s
    7
    FEI Numbers
    220
    Registration Numbers
    220
    Unique Applicants
    6
    Years Active
    4

    Basic Information

    Product Code
    KNP
    Device Class
    FDA class 1
    Regulation Number
    890.3475
    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 7 510(k) clearances via K numbers.

    K Number Device Name
    K831690 IPOS ANTI-ADDUCTUS SHOE
    K831552 SORBOTHANE VISCO INNER SOLE PAD
    K823654 SLIP-ON SANDALS FOR MEASURING SHORTNESS
    K823665 ROTATION BOOT
    K810228 SORBOTHANE
    K801743 PLASTAZOTE SHOE
    K790326 DRUSHOE

    FEI Numbers

    This FDA classification entry is associated with 220 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 220 registration numbers. Click on an entry to view related FDA registrations.