BEUDAMED
    Product Code: INF FDA class 1 21 CFR 890.3940

    Scale, Platform, Wheelchair

    Physical Medicine

    A Wheelchair Platform Scale is a weighing device designed to accommodate a wheelchair-seated patient, allowing accurate body weight measurement without requiring a transfer from the wheelchair, used in clinical settings for patients who cannot stand on a standard scale. 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 INF, regulated under 21 CFR 890.3940, within the Physical Medicine medical specialty. This device is GMP exempt, indicating it is not subject to full good manufacturing practice requirements.

    View on FDA
    510(k)s
    5
    FEI Numbers
    32
    Registration Numbers
    32
    Unique Applicants
    4
    Years Active
    16

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    Basic Information

    Product Code
    INF
    Device Class
    FDA class 1
    Regulation Number
    890.3940
    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 5 510(k) clearances via K numbers.

    K Number Device Name
    K924441 U.S. MEDICAL PS-6000 WHEELCHAIR SCALE
    K910055 ACME MODEL 8500 WHEELCHAIR SCALE
    K884908 ULTRAFLOTATION MEDICAL WHEELCHAIR
    K871391 AMIGO-A288310 (SCOOTER, COMMUTER CART, 3-WHEELED)
    K760327 WHEEL'N WEIGH

    FEI Numbers

    This FDA classification entry is associated with 32 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 32 registration numbers. Click on an entry to view related FDA registrations.