Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Stimulator, Neuromuscular, External Functional
510(k) Number K123972
Device Name WALKAIDE SYSTEM
Applicant
Innovative Neurotronics, Inc.
3600-B N. Capital Of Texas Hwy
Suite 150
Austin,  TX  78746 -3211
Applicant Contact GLEN NEALLY
Correspondent
Innovative Neurotronics, Inc.
3600-B N. Capital Of Texas Hwy
Suite 150
Austin,  TX  78746 -3211
Correspondent Contact GLEN NEALLY
Regulation Number882.5810
Classification Product Code
GZI  
Date Received12/26/2012
Decision Date 04/01/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-