BEUDAMED
    Product Code: KID FDA class 1 21 CFR 890.3910

    Restraint, Wheelchair, Non-Protective

    Physical Medicine

    Non-Protective Wheelchair Restraint is a positioning device used to secure or stabilize a patient in a wheelchair to prevent sliding or falling out, without providing a protective function designed to withstand crash or impact forces, intended for use in clinical and care settings where patient positioning assistance is needed. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KID, regulated under 21 CFR 890.3910, within the Physical Medicine medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.

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    510(k)s
    7
    FEI Numbers
    41
    Registration Numbers
    41
    Unique Applicants
    3
    Years Active
    16

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    Basic Information

    Product Code
    KID
    Device Class
    FDA class 1
    Regulation Number
    890.3910
    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
    K963479 WHEELCHAIR BELT
    K963480 MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER
    K963475 PONCHO VEST RESTRAINT
    K963459 SUPPORT VEST
    K963461 SAFETY PONCHO/SHOULDER STRAP PONCHO
    K963455 SLEEVED JACKET/SLEEVED JACKET WITH SLIDER CONTROL
    K802603 ECONO-FLOAT WHEELCHAIR FLOTATION CUSHION

    FEI Numbers

    This FDA classification entry is associated with 41 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 41 registration numbers. Click on an entry to view related FDA registrations.