The following data is part of a premarket notification filed by Otto Bock Healthcare Products Gmbh with the FDA for Mygait Stimulation System.
| Device ID | K141812 |
| 510k Number | K141812 |
| Device Name: | MYGAIT STIMULATION SYSTEM |
| Classification | Stimulator, Neuromuscular, External Functional |
| Applicant | OTTO BOCK HEALTHCARE PRODUCTS GMBH KAISERSTRASSE 39 Vienna, AT 1070 |
| Contact | Rene Urtz |
| Correspondent | Rene Urtz OTTO BOCK HEALTHCARE PRODUCTS GMBH KAISERSTRASSE 39 Vienna, AT 1070 |
| Product Code | GZI |
| CFR Regulation Number | 882.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-07 |
| Decision Date | 2015-04-02 |
| Summary: | summary |