DIAGNOSTIC ELECTROMYOGRAPHY NEEDLE ELECTRODE, DISPOSABLE HYPODERMIC NEEDLE
Device Facts
| Record ID | K001869 |
|---|---|
| Device Name | DIAGNOSTIC ELECTROMYOGRAPHY NEEDLE ELECTRODE, DISPOSABLE HYPODERMIC NEEDLE |
| Applicant | Medicotest A/S |
| Product Code | IKT · Physical Medicine |
| Decision Date | Sep 18, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.1385 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A diagnostic electromyograph needle electrode is a monopolar or bipolar needle intended to be inserted into muscle or nerve tissue to sense bioelectrical signals. The device is intended for medical purposes for use in connection with electromyography (recording the intrinsic electrical properties of skeletal muscle).
