K200262 is an FDA 510(k) clearance for the L100 Go System. 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 March 4, 2020, 30 days after receiving the submission on February 3, 2020.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5810.
| 510(k) Number | K200262 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 03, 2020 |
| Decision Date | March 04, 2020 |
| Days to Decision | 30 days |
| Submission Type | Special |
| 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 |