GZI · Class II · 21 CFR 882.5810

FDA Product Code GZI: Stimulator, Neuromuscular, External Functional

Leading manufacturers include Bioness, Inc., Restorative Therapies, Inc. and Ness-Neuromuscular Electrical Stimulation Systems.

61
Total
61
Cleared
153d
Avg days
1977
Since
61 devices
25–48 of 61
Cleared Aug 08, 2014
WALKAIDE SYSTEM
K140886
Innovative Neurotronics, Inc.
Neurology · 123d
Cleared Jul 03, 2014
NEURODYN PORTABLE TENS NFES, NEURODYN PORTABLE TENS
K131923
Techlink International
Neurology · 372d
Cleared May 28, 2014
REHASTIM 2, ERIGOPRO (FES)
K132416
Hasomed GmbH
Neurology · 299d
Cleared May 01, 2013
H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE TRIGGERING DEVICE
K123636
Bioness, Inc.
Neurology · 159d
Cleared Apr 01, 2013
WALKAIDE SYSTEM
K123972
Innovative Neurotronics, Inc.
Neurology · 96d
Cleared Dec 27, 2012
NESS L300 SYSTEM KIT, LEF MODEL LG3-5100
K122784
Bioness, Inc.
Neurology · 107d
Cleared Apr 20, 2012
NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT,
K120853
Bioness, Inc.
Neurology · 30d
Cleared Oct 27, 2011
REHASTIM 2, REHAMOVE 2
K112844
Hasomed GmbH
Neurology · 28d
Cleared Sep 15, 2011
NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT
K111767
Ness-Neuromuscular Electrical Stimulation Systems
Neurology · 84d
Cleared Apr 29, 2011
L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT)
K103343
Bioness, Inc.
Neurology · 165d
Cleared Apr 05, 2011
RT200
K103370
Restorative Therapies, Inc.
Neurology · 139d
Cleared Apr 04, 2011
RT600
K103366
Restorative Therapies, Inc.
Neurology · 139d
Cleared Mar 30, 2011
ODFS PACE
K102115
Odstock Medical, Ltd.
Neurology · 245d
Cleared Aug 05, 2009
RT300-SL, MODEL FA100052
K090750
Restorative Therapies, Inc.
Neurology · 138d
Cleared Feb 28, 2008
MODIFICATION TO:NESS L300
K080219
Ness-Neuromuscular Electrical Stimulation Systems
Neurology · 30d
Cleared Dec 27, 2007
REHASTIM & REHAMOVE
K073237
Hasomed GmbH
Neurology · 41d
Cleared Nov 21, 2007
RT300-S AND RT300-SP FES CYCLE ERGOMETER
K072398
Restorative Therapies, Inc.
Neurology · 86d
Cleared Sep 10, 2007
RT300-S, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, FA100053
K071486
Restorative Therapies, Inc.
Neurology · 103d
Cleared Jul 05, 2007
RT300-S, MODEL FA100052, RT300-SP (PEDIATRIC VERSION), MODEL FA100053
K071113
Restorative Therapies, Inc.
Neurology · 76d
Cleared Jul 07, 2006
NESS L300
K053468
Ness-Neuromuscular Electrical Stimulation Systems
Neurology · 206d
Cleared Mar 10, 2006
RT300-S, MODEL FA100052
K060032
Restorative Therapies, Inc.
Neurology · 64d
Cleared Sep 21, 2005
WALKAIDE SYSTEM, MODELS 20-0100, 20-0310, 20-1000
K052329
Innovative Neurotronics, Inc.
Neurology · 27d
Cleared Jul 15, 2005
THE ODFS DROPPED FOOT STIMULATOR
K050991
Department of Medical Physics and Biomedical Eng.
Neurology · 87d
Cleared Jun 27, 2005
FES CYCLE ERGOMETER, MODEL RT300-S
K050036
Restorative Therapies, Inc.
Neurology · 171d