K141812 is an FDA 510(k) clearance for the MYGAIT STIMULATION SYSTEM. This device is classified as a Stimulator, Neuromuscular, External Functional (Class II - Special Controls, product code GZI).
Submitted by Otto Bock Healthcare Products GmbH (Vienna, AT). The FDA issued a Cleared decision on April 2, 2015, 269 days after receiving the submission on July 7, 2014.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5810.
| 510(k) Number | K141812 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 07, 2014 |
| Decision Date | April 02, 2015 |
| Days to Decision | 269 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 |