Atlas FDA

GZI

61 FDA 510(k) clearances · Product code

123 daysmedian time to decision
308 days90th percentile
61clearances measured

FDA profile

Official device name
Stimulator, Neuromuscular, External Functional
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5810
Medical specialty
Neurology
Flags
Third-party review eligible
Adverse events (MAUDE)
1995: 2 · 1996: 3 · 1997: 1 · 2000: 1 · 2005: 2 · 2009: 8
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Synchrony (20-3000) (K242704)Synapse Biomedical, Inc.2025-06-05
CIONIC NEURAL SLEEVE (NS-200) (K243828)Cionic, Inc.2025-05-02
Neuvotion NeuStim NN-01 (K240632)Neuvotion, Inc.2024-11-22
MyndMove, MyndMove 2.0 (K233006)Myndtec, Inc.2024-06-25
EvoWalk 1.0 System (K230997)Evolution Devices, Inc.2023-12-28
Cionic Neural Sleeve NS-100 (K221823)Cionic2022-07-21
MyoCycle MC-2 (Home / Home + / Pro / Pro +) (K213925)Myolyn, LLC2022-04-25
MyndMove 2.0 (K212149)Myndtec, Inc.2022-03-03
Cionic Neural Sleeve NS-100 (K213622)Cionic2022-02-14
MStim Drop Model: LGT-233 (K202110)Guangzhou Longest Science & Technology Co., Ltd.2021-11-05
Nerve and Muscle Stimulator (K193276)Shenzhen Xft Medical Limited2020-09-23
L100 Go System (K200262)Bioness, Inc.2020-03-04
L360 Thigh System (K191587)Bioness, Inc.2019-09-12
L300 Go System (K190285)Bioness, Inc.2019-03-14
L300 Go System (K173682)Bioness, Inc.2018-03-09
ODFS Pace XL (K171396)Odstock Medical, Ltd.2018-01-31
Foot Drop System (Model XFT-2001D) (K162718)Shenzhen Xft Medical Limited2017-11-30
MyndMove System, MyndMove Functional Electrical Stimulator (K170564)Myndtec, Inc.2017-08-30
RT300 FES cycle ergometer (K162470)Restorative Therapies, Inc.2017-07-11
MyoCycle Home, MyoCycle Pro (K170132)Myolyn, LLC2017-04-25
RehaStim 2 (K162683)Hasomed GmbH2017-02-03
L300 Go System (K162407)Bioness, Inc.2017-01-27
ReGrasp (K153163)Rehabtronics, Inc.2016-04-07
MYGAIT STIMULATION SYSTEM (K141812)Otto Bock Healthcare Products GmbH2015-04-02
WALKAIDE SYSTEM (K140886)Innovative Neurotronics, Inc.2014-08-08
NEURODYN PORTABLE TENS NFES, NEURODYN PORTABLE TENS (K131923)Techlink International2014-07-03
REHASTIM 2, ERIGOPRO (FES) (K132416)Hasomed GmbH2014-05-28
H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE TRIGGERING DEVICE (K123636)Bioness, Inc.2013-05-01
WALKAIDE SYSTEM (K123972)Innovative Neurotronics, Inc.2013-04-01
NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM KIT, RIGHT MODEL LG3-5000; SMALL NESS L300 SYSTEM KIT, RIGHT (K122784)Bioness, Inc.2012-12-27
NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, (K120853)Bioness, Inc.2012-04-20
REHASTIM 2, REHAMOVE 2 (K112844)Hasomed GmbH2011-10-27
NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT (K111767)Ness-Neuromuscular Electrical Stimulation Systems2011-09-15
L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT) (K103343)Bioness, Inc.2011-04-29
RT200 (K103370)Restorative Therapies, Inc.2011-04-05
RT600 (K103366)Restorative Therapies, Inc.2011-04-04
ODFS PACE (K102115)Odstock Medical, Ltd.2011-03-30
RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581 (K090750)Restorative Therapies, Inc.2009-08-05
MODIFICATION TO:NESS L300 (K080219)Ness-Neuromuscular Electrical Stimulation Systems2008-02-28
REHASTIM & REHAMOVE (K073237)Hasomed GmbH2007-12-27
RT300-S AND RT300-SP FES CYCLE ERGOMETER (K072398)Restorative Therapies, Inc.2007-11-21
RT300-S, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, FA100053 (K071486)Restorative Therapies, Inc.2007-09-10
RT300-S, MODEL FA100052, RT300-SP (PEDIATRIC VERSION), MODEL FA100053 (K071113)Restorative Therapies, Inc.2007-07-05
NESS L300 (K053468)Ness-Neuromuscular Electrical Stimulation Systems2006-07-07
RT300-S, MODEL FA100052; RT300-SP, MODEL FA100053 (K060032)Restorative Therapies, Inc.2006-03-10
WALKAIDE SYSTEM, MODELS 20-0100, 20-0310, 20-1000 (K052329)Innovative Neurotronics, Inc.2005-09-21
THE ODFS DROPPED FOOT STIMULATOR (K050991)Department of Medical Physics and Biomedical Eng.2005-07-15
FES CYCLE ERGOMETER, MODEL RT300-S (K050036)Restorative Therapies, Inc.2005-06-27
HANDMASTER (K031900)Ness-Neuromuscular Electrical Stimulation Systems2003-08-08
MODIFICATION TO HANDMASTER (K012823)Ness-Neuromuscular Electrical Stimulation Systems2001-11-14
HANDMASTER (K010837)Neuromusclar Electrical Stimulation Systems, Ltd.2001-06-15
EXTERNAL FUNCTIONAL NEUROMUSCULAR STIMULATOR (K974514)Neuromotion, Inc.1998-02-06
FORTE ES (K940759)Chattanooga Group, Inc.1995-03-16
COMFORTRON PT (TENS) (K911066)M. D. Supply, Inc.1992-02-07
ROCHE COBAS ARGOS 5 DIFF (K912615)Roche Diagnostic Systems, Inc.1991-09-27
SELECT NEUROMUSCULAR STIMULATORS (K903434)Medtronic Vascular1991-08-09
TENS LEAD (K873608)Desco Industries, Inc.1987-09-30
VERI/DFS TM #817 (K813515)Verite1982-01-19
FES ORTHOSIS MODEL NO. 2000 (K800380)Empi1980-03-17
NERVE STIMULATOR, MOLEL NO. FB-800 (K770987)Output, Inc.1977-06-14
STIMULATOR, MUSCLE, MODEL 107 (K770725)Jaytronics, Inc.1977-04-26

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