BEUDAMED
    Product Code: ILW FDA class 1 21 CFR 890.5050

    Adaptor, Grooming

    Physical Medicine

    A Grooming Adaptor is an assistive device used in Physical Medicine and occupational therapy to help patients with limited hand function, upper limb weakness, or impaired dexterity to independently perform personal grooming tasks such as hair care, shaving, and nail care. 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 ILW, 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.

    View on FDA
    510(k)s
    7
    FEI Numbers
    42
    Registration Numbers
    42
    Unique Applicants
    1
    Years Active
    6

    Research product code ILW in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    ILW
    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

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 7 510(k) clearances via K numbers.

    K Number Device Name
    K823632 LONG HANDLED FOLDING HAIRBRUSH
    K810457 GROOMING ADAPTORS
    K781200 NAIL CLIPPERS, ONE-HANDED
    K781197 STICK, UTILITY
    K761123 ELECTRIC RAZOR HOLDER
    K760293 MIRROR, EXTEND-A-, BK-6235
    K760289 BRUSH, DISPOSA-A (HANDLE, REFILL PKG)

    FEI Numbers

    This FDA classification entry is associated with 42 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 42 registration numbers. Click on an entry to view related FDA registrations.