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
49–61 of 61
Cleared Aug 08, 2003
HANDMASTER
K031900
Ness-Neuromuscular Electrical Stimulation Systems
Neurology · 50d
Cleared Nov 14, 2001
MODIFICATION TO HANDMASTER
K012823
Ness-Neuromuscular Electrical Stimulation Systems
Neurology · 90d
Cleared Jun 15, 2001
HANDMASTER
K010837
Neuromusclar Electrical Stimulation Systems, Ltd.
Neurology · 87d
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
Cleared Feb 07, 1992
COMFORTRON PT (TENS)
K911066
M. D. Supply, Inc.
Neurology · 333d
Cleared Sep 27, 1991
ROCHE COBAS ARGOS 5 DIFF
K912615
Roche Diagnostic Systems, Inc.
Hematology · 106d
Cleared Aug 09, 1991
SELECT NEUROMUSCULAR STIMULATORS
K903434
Medtronic Vascular
Neurology · 374d
Cleared Sep 30, 1987
TENS LEAD
K873608
Desco Industries, Inc.
Neurology · 22d
Cleared Jan 19, 1982
VERI/DFS TM #817
K813515
Verite
Neurology · 35d
Cleared Mar 17, 1980
FES ORTHOSIS MODEL NO. 2000
K800380
Empi
Neurology · 24d
Cleared Jun 14, 1977
NERVE STIMULATOR, MOLEL NO. FB-800
K770987
Output, Inc.
Neurology · 14d
Cleared Apr 26, 1977
STIMULATOR, MUSCLE, MODEL 107
K770725
Jaytronics, Inc.
Neurology · 7d