DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, VAR MODELS
Device Facts
| Record ID | K912282 |
|---|---|
| Device Name | DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, VAR MODELS |
| Applicant | Chalgren Enterprises, Inc. |
| Product Code | IKT · Physical Medicine |
| Decision Date | Mar 16, 1992 |
| 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).
