FES ORTHOSIS MODEL NO. 2000
Device Facts
| Record ID | K800380 |
|---|---|
| Device Name | FES ORTHOSIS MODEL NO. 2000 |
| Applicant | Empi |
| Product Code | GZI · Neurology |
| Decision Date | Mar 17, 1980 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.5810 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait.
