BEUDAMED
    Product Code: IKY FDA class 1 21 CFR 880.5150

    Mattress, Flotation Therapy, Non-Powered

    General Hospital

    A Non-Powered Flotation Therapy Mattress is a passive pressure-distributing mattress used in general hospital and Physical Medicine settings to reduce pressure on bony prominences and help prevent or manage pressure ulcers in patients with limited mobility. 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 IKY, regulated under 21 CFR 880.5150, within the General Hospital 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
    8
    FEI Numbers
    154
    Registration Numbers
    154
    Unique Applicants
    6
    Years Active
    15

    Basic Information

    Product Code
    IKY
    Device Class
    FDA class 1
    Regulation Number
    880.5150
    Medical Specialty
    General Hospital
    Review Panel
    HO
    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 8 510(k) clearances via K numbers.

    K Number Device Name
    K914921 SCM-3 AND ACCESSORIES
    K813226 GEL FLOTATION MATTRESS
    K802833 TETRA NATAL-MAT WATER FLOTATION MAT.
    K802781 BEDDING PADS EGGCREATE PADS
    K780779 ECONO-FLOAT WATER FLOTATION MATTRESS
    K772062 NEONATAL FLOTATION SYSTEM
    K771824 MEDPRO FLOTATION SYSTEM
    K760963 DECUBITUS MATTRESS

    FEI Numbers

    This FDA classification entry is associated with 154 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 154 registration numbers. Click on an entry to view related FDA registrations.