NM-01/CPT neurometer (NM-01/CPT)

The NM-01/CPT neurometer is a non-invasive electrodiagnostic device that measures nerve conduction by determining sensory nerve conduction thresholds in conscious adult patients with intact skin. It is intended to verify nerve integrity and evaluate patients suspected of having neuropathies as part of routine neurological examination, for use in medical clinics and hospitals.

The device uses sinusoidal stimulus at 5Hz, 250Hz, and 2000Hz frequencies with 0.001 mA resolution, powered by rechargeable internal battery, and features Bluetooth connectivity and software-based control across multiple operating systems (Windows, iOS, Android). It has permanent gold-coated electrodes, tests small unmyelinated (C), small myelinated (Aδ), and large myelinated (Aβ) sensory nerve fibers, and includes normative values for over 30 testing sites with automatic sensor displacement detection.

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The NM-01/CPT is substantially equivalent to the Neurometer CPT (K843924) predicate because both devices perform identical functional measurements—automated neuroselective sensory nerve conduction threshold evaluations using current perception threshold methodology. Both use sinusoidal stimulation at the same frequencies (5Hz, 250Hz, 2000Hz) with equivalent resolution (0.001 mA), rechargeable battery power, and verbal/remote-based detection methods. Bench testing confirmed measurement equivalence within 10% confidence intervals across resistance values, demonstrating that the two instruments produce equivalent results in the measurement domain for the intended diagnostic use of peripheral neuropathy evaluation.