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 |