GZI · Class II · 21 CFR 882.5810

FDA Product Code GZI: Stimulator, Neuromuscular, External Functional

Leading manufacturers include Bioness, Inc., Restorative Therapies, Inc. and Hasomed GmbH.

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 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
Cleared Feb 06, 1998
EXTERNAL FUNCTIONAL NEUROMUSCULAR STIMULATOR
K974514
Neuromotion, Inc.
Neurology · 67d
Cleared Mar 16, 1995
FORTE ES
K940759
Chattanooga Group, Inc.
Neurology · 391d