BEUDAMED
    Product Code: GWI FDA class 1 21 CFR 882.1200

    Discriminator, Two-Point

    Neurology

    The Discriminator, Two-Point is a simple neurological diagnostic instrument used to assess tactile spatial discrimination by determining the minimum distance at which a patient can distinguish two simultaneous points of contact on the skin, a test of sensory nerve function. It is an FDA Class 1 device subject only to general controls with no premarket submission required, and it is GMP exempt. Regulated under 21 CFR 882.1200 with product code GWI in the Neurology specialty. No other special flags apply to this device.

    View on FDA
    510(k)s
    2
    FEI Numbers
    16
    Registration Numbers
    16
    Unique Applicants
    2
    Years Active
    7

    Basic Information

    Product Code
    GWI
    Device Class
    FDA class 1
    Regulation Number
    882.1200
    Medical Specialty
    Neurology
    Review Panel
    NE
    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 2 510(k) clearances via K numbers.

    K Number Device Name
    K944234 TCD OR TCD NEUROPATHY STAR
    K874300 AESTHESIOMETER

    FEI Numbers

    This FDA classification entry is associated with 16 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 16 registration numbers. Click on an entry to view related FDA registrations.