NEUROMATIC 2000
Device Facts
| Record ID | K821237 |
|---|---|
| Device Name | NEUROMATIC 2000 |
| Applicant | Disa Electronics |
| Product Code | IKN · Physical Medicine |
| Decision Date | May 21, 1982 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.1375 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.