TENS-IT, FITTRONIC II, (MORE LATER)
Device Facts
| Record ID | K946018 |
|---|---|
| Device Name | TENS-IT, FITTRONIC II, (MORE LATER) |
| Applicant | Ems, Inc. |
| Product Code | GZL · Neurology |
| Decision Date | Nov 9, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.1330 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.