• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
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 K122784
Model LG3-5100; LG3-5000; LG3-5U00; LG3-5V00; L3P-5000, L3P-5001, RESPECTIVELY
Device Name NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM KIT, RIGHT MODEL LG3-5000; SMALL NESS L300 SYSTEM KIT, RIGHT
Original Applicant
BIONESS, INC.
25103 rye canyon loop
valencia,  CA  91355
Original Contact kim tompkins
Regulation Number882.5810
Classification Product Code
GZI  
Subsequent Product Code
IPF  
Date Received09/11/2012
Decision Date 12/27/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Ear Nose & Throat
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-