BEUDAMED
    Product Code: ILT FDA class 1 21 CFR 890.5050

    Adaptor, Recreational

    Physical Medicine

    A Recreational Adaptor is an assistive device used in Physical Medicine and occupational therapy to enable individuals with physical disabilities to participate in leisure and recreational activities by adapting standard recreational equipment for use with limited hand function or 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 ILT, regulated under 21 CFR 890.5050, within the Physical Medicine 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
    7
    FEI Numbers
    61
    Registration Numbers
    61
    Unique Applicants
    1
    Years Active
    6

    Basic Information

    Product Code
    ILT
    Device Class
    FDA class 1
    Regulation Number
    890.5050
    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
    K823657 CARD HOLDER FOR QUADS
    K823656 SOFT CATCHER'S MITT
    K781199 HOLDER, CARD, QUAD-QUIP
    K761116 BREATH CONTROL GAME
    K760306 CARDS, GIANT FACE PLAYING BK-9419
    K760291 HOLDER, PENCIL & CRAYON, WITH STAND
    K760288 VIEWER, RECLINING, BK-4089

    FEI Numbers

    This FDA classification entry is associated with 61 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 61 registration numbers. Click on an entry to view related FDA registrations.