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 |