The following data is part of a premarket notification filed by Innovative Neurotronics Inc. with the FDA for Walkaide System.
| Device ID | K140886 |
| 510k Number | K140886 |
| Device Name: | WALKAIDE SYSTEM |
| Classification | Stimulator, Neuromuscular, External Functional |
| Applicant | INNOVATIVE NEUROTRONICS INC. 3600-B N. CAPITAL OF TEXAS HWY BLDG. B SUITE 150 Austin, TX 78746 -3211 |
| Contact | Glen Neally |
| Correspondent | Glen Neally INNOVATIVE NEUROTRONICS INC. 3600-B N. CAPITAL OF TEXAS HWY BLDG. B 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 | 2014-04-07 |
| Decision Date | 2014-08-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858184006130 | K140886 | 000 |
| 00858184006062 | K140886 | 000 |
| 00858184006055 | K140886 | 000 |
| 00858184006048 | K140886 | 000 |
| 00858184006031 | K140886 | 000 |
| 00858184006017 | K140886 | 000 |
| 00858184006000 | K140886 | 000 |