The following data is part of a premarket notification filed by Innovative Neurotronics Inc. with the FDA for Walkaide System.
| Device ID | K123972 |
| 510k Number | K123972 |
| Device Name: | WALKAIDE SYSTEM |
| Classification | Stimulator, Neuromuscular, External Functional |
| Applicant | INNOVATIVE NEUROTRONICS INC. 3600-B N. CAPITAL OF TEXAS HWY SUITE 150 Austin, TX 78746 -3211 |
| Contact | Glen Neally |
| Correspondent | Glen Neally INNOVATIVE NEUROTRONICS INC. 3600-B N. CAPITAL OF TEXAS HWY SUITE 150 Austin, TX 78746 -3211 |
| Product Code | GZI |
| CFR Regulation Number | 882.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-26 |
| Decision Date | 2013-04-01 |
| Summary: | summary |