The following data is part of a premarket notification filed by Innovative Neurotronics Inc. with the FDA for Walkaide System, Models 20-0100, 20-0310, 20-1000.
| Device ID | K052329 |
| 510k Number | K052329 |
| Device Name: | WALKAIDE SYSTEM, MODELS 20-0100, 20-0310, 20-1000 |
| Classification | Stimulator, Neuromuscular, External Functional |
| Applicant | INNOVATIVE NEUROTRONICS INC. TWO BETHESDA METRO CENTER SUTE 1200 Bethesda, MD 20814 |
| Contact | Fayyaz Memon |
| Correspondent | Fayyaz Memon INNOVATIVE NEUROTRONICS INC. TWO BETHESDA METRO CENTER SUTE 1200 Bethesda, MD 20814 |
| Product Code | GZI |
| CFR Regulation Number | 882.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-25 |
| Decision Date | 2005-09-21 |
| Summary: | summary |