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 K052329
Device Name WALKAIDE SYSTEM, MODELS 20-0100, 20-0310, 20-1000
Applicant
INNOVATIVE NEUROTRONICS INC.
TWO BETHESDA METRO CENTER
SUTE 1200
BETHESDA,  MD  20814
Applicant Contact FAYYAZ MEMON
Correspondent
INNOVATIVE NEUROTRONICS INC.
TWO BETHESDA METRO CENTER
SUTE 1200
BETHESDA,  MD  20814
Correspondent Contact FAYYAZ MEMON
Regulation Number882.5810
Classification Product Code
GZI  
Date Received08/25/2005
Decision Date 09/21/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-