BEUDAMED
    Product Code: NTU FDA class 2 21 CFR 882.1870

    Evoked Potential Stimulator, Thermal

    Neurology

    The Thermal Evoked Potential Stimulator is a neurological device intended to evaluate the functionality of human pain reception and transmission of sensory pathways by delivering controlled thermal stimuli and measuring the resulting evoked potentials. It is used in the assessment of somatosensory and pain-related neural function. It is an FDA Class 2 device regulated under 21 CFR 882.1870 in the Neurology specialty, with product code NTU, requiring 510(k) clearance. Third-party review is available. It is not an implant and does not carry life-sustaining support designation.

    View on FDA
    510(k)s
    3
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    1
    Years Active
    1

    Basic Information

    Product Code
    NTU
    Device Class
    FDA class 2
    Regulation Number
    882.1870
    Medical Specialty
    Neurology
    Review Panel
    NE
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Intended to evaluate the functionality of human pain reception and transmission of sensory pathways

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 3 510(k) clearances via K numbers.

    K Number Device Name
    K052357 PATHWAY - ATS/CHEPS
    K051448 MODIFIED CONTACT-HEAT EVOKED POTENTIAL STIMULATOR (CHEPS)
    K041908 CONTACT HEAT-EVOKED POTENTIAL STIMULATOR (CHEPS)

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.