NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT,
Device Facts
| Record ID | K120853 |
|---|---|
| Device Name | NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, |
| Applicant | Bioness, Inc. |
| Product Code | GZI · Neurology |
| Decision Date | Apr 20, 2012 |
| Decision | SESE |
| Submission Type | Special |
| 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.
