K122784 is an FDA 510(k) clearance for the NESS L300 SYSTEM KIT, LEF MODEL LG3-5100. This device is classified as a Stimulator, Neuromuscular, External Functional (Class II - Special Controls, product code GZI).
Submitted by Bioness, Inc. (Valencia, US). The FDA issued a Cleared decision on December 27, 2012, 107 days after receiving the submission on September 11, 2012.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5810.
| 510(k) Number | K122784 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 2012 |
| Decision Date | December 27, 2012 |
| Days to Decision | 107 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GZI - Stimulator, Neuromuscular, External Functional |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5810 |