Device Dossier
Stimulator, electrical, neuromuscular, diagnostic
Device Dossier for Stimulator, electrical, neuromuscular, diagnostic (Stimulator, electrical, neuromuscular, diagnostic, Class IIa, sponsor LMT…
- GMDN category: Stimulator, electrical, neuromuscular, diagnostic
Intended purpose
The Mediracer NCS is intended to measure sensory and motor nerve conduction from peripheral nerves. The measured data can be utilized in evaluating patients suspected of having focal neuropathies. The measured data must be used in the context of other patient information and must be reviewed and interpreted by a physician. Testing is conducted using disposable, non-invasive single patient use Electrodes designed for the product. The nerve is stimulated with electric pulses and the Nerve responses are recorded. The measured data is automatically transferred to a PC via Bluetooth. The Nerve response data is displayed on the PC screen with Mediracer Analysis Center (MAC) software and from that data can be found information on the condition of the nerve between the stimulus and recording points.