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510(k) Data Aggregation

    K Number
    K240189
    Device Name
    NM-01/CPT neurometer (NM-01/CPT)
    Manufacturer
    MDE Orvosbiológiai Kutató, Fejleszto,
    Date Cleared
    2025-03-26

    (427 days)

    Product Code
    JXE
    Regulation Number
    882.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    MDE Orvosbiológiai Kutató, Fejleszto,

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NM-01/CPT neurometer is a noninvasive electrodiagnostic device intended for verifying nerve integrity in conscious adult patients, with intact skin surface. The population of subject for whom this device may be used for diagnostic purposes would include any individual capable of communicating their perception of cutaneous sensation. The NM-01/CPT neurometer may be conducted as a part of a routine neurological examination. The measured data can be utilized in evaluating patients suspected of having neuropathies. The measured data must be used in the context of other patient information and must be reviewed and interpreted by a physician. The device is intended for use on adults in medical clinics, healthcare practices and out-patient departments of hospitals.
    Device Description
    The NM-01/CPT neurometer is a noninvasive device intentity in conscious adult patients, with intact skin surface. The population of subject for whom this device may be used for diagnostic purposes would include any individual capable of communicating their perception of cutaneous sensation. The NM-01/CPT neurometer may be conducted as a part of a routine neurological examination. The measured data can be utilized in evaluating patients suspected of having neuropathies. The measured data must be used in the context of other patient information and interpreted by a physician. The device is intended for use on adults in medical clinics, healthcare practices and out-patient departments of hospitals. The NEUROMETER NM-01/CPT is a unique neurodiagnostic device that painlessly evaluates the functioning of small unmyelinated (C, small myelinated (A) and large myelinated (A) sensory nerve fibers at any cutaneous site by determining neuro selective sensory nerve conduction threshold. The electronic unit emits non-aversive transcutaneous electrical stimuli through a pair of special noninvasive electrodes in three fixed frequency ranges (thick myelincoated fiber 250Hz, thin myelin-coated fiber 2000Hz) with a manually adjustable current value. The emitted stimulus pulses canbe changed between 0.01 and 9.99 mA and their values qiven by the software are in CPT (Current Precipitation Threshold) values accepted in clinical practice (1CPT = 0.01mA). The test method is sensitive to both hyperesthetic abnormalities, and has more than 800 peer reviewed research publications documenting its diagnostic capabilities. The device can measure sensory nerve function at any cutaneous site including mucosal surfaces such as the bladder and the measures are not affected by skin temperature, edema or electromag-netic interference unlike traditional electro-diagnostic and biopsy procedures. The conducted tests are painless, noninvasive and non-aversive procedure is easy to perform and safe and harmless however it is only for profession clinical use. The evaluation of the tests result could only be approved by a medical doctor but the tests could be conducted by a trained assistant.
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