• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • 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 stimulator, neuromuscular, external functional
Regulation Description External functional neuromuscular stimulator.
Product CodeGZI
Regulation Number 882.5810
Device Class 2


Premarket Reviews
ManufacturerDecision
BIONESS, INC.
  SUBSTANTIALLY EQUIVALENT 3
CHATTANOOGA GROUP
  SUBSTANTIALLY EQUIVALENT 1
EMPI
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
OTTO BOCK HEALTHCARE, GMBH
  SUBSTANTIALLY EQUIVALENT 1
RESTORATIVE THERAPIES INC.
  SUBSTANTIALLY EQUIVALENT 8
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fracture 4
Shaft break 3
Detachment of device component 2
Intermittent continuity 1
Device, or device fragments remain in patient 1
Total Device Problems 11

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 1 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Innovative Neurotronics, Inc. II Jun-03-2009

-
-