BEUDAMED
    Product Code: FZF FDA class 1 21 CFR 878.3900

    Splint, Extremity, Inflatable, External

    General, Plastic Surgery

    The Splint, Extremity, Inflatable, External (product code FZF) is an external inflatable device used to immobilize and support injured extremities, typically applied following fractures, sprains, or other traumatic injuries to limbs. It is classified as FDA Class 1, the lowest risk category, meaning it is subject only to general controls such as proper labeling and manufacturing standards, with no premarket notification required. The device falls under 21 CFR 878.3900 within the General, Plastic Surgery specialty (SU). No special flags apply to this device.

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    510(k)s
    7
    FEI Numbers
    51
    Registration Numbers
    51
    Unique Applicants
    4
    Years Active
    5

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    Basic Information

    Product Code
    FZF
    Device Class
    FDA class 1
    Regulation Number
    878.3900
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    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
    K881516 COMPRESAID
    K874053 INFLATABLE FULL ARM SPLINT
    K874052 INFLATABLE HALF LEG SPLINT
    K874051 INFLATABLE FULL LEG SPLINT
    K874050 INFLATABLE FOOT & ANKLE SPLINT
    K853600 INFLATABLE AIR SPLINTS
    K831764 URIAS PRESSURE SPLINTS, & FIRST AID

    FEI Numbers

    This FDA classification entry is associated with 51 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 51 registration numbers. Click on an entry to view related FDA registrations.