FDA 510(k) Applications for Medical Device Product Code "GZI"
(Stimulator, Neuromuscular, External Functional)

FDA 510(k) Number Applicant Device Name Decision Date
K200262 Bioness Inc. L100 Go System 03/04/2020
K162407 BIONESS INC. L300 Go System 01/27/2017
K190285 Bioness Inc. L300 Go System 03/14/2019
K103343 BIONESS INC. L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT) 04/29/2011
K191587 Bioness Inc. L360 Thigh System 09/12/2019
K123636 BIONESS, INC. H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE TRIGGERING DEVICE 05/01/2013
K173682 Bioness, Inc. L300 Go System 03/09/2018
K122784 BIONESS, INC. NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM KIT, RIGHT MODEL LG3-5000; SMALL NESS L300 SYSTEM KIT, RIGHT 12/27/2012
K120853 BIONESS, INC. NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, 04/20/2012
K213622 CIONIC Cionic Neural Sleeve NS-100 02/14/2022
K221823 CIONIC Cionic Neural Sleeve NS-100 07/21/2022
K050991 DEPARTMENT OF MEDICAL PHYSICS AND BIOMEDICAL ENG. THE ODFS DROPPED FOOT STIMULATOR 07/15/2005
K202110 Guangzhou Longest Science & Technology CO., Ltd. MStim Drop Model: LGT-233 11/05/2021
K073237 HASOMED GMBH REHASTIM & REHAMOVE 12/27/2007
K162683 HASOMED GmbH RehaStim 2 02/03/2017
K132416 HASOMED GMBH REHASTIM 2, ERIGOPRO (FES) 05/28/2014
K112844 HASOMED GMBH REHASTIM 2, REHAMOVE 2 10/27/2011
K123972 INNOVATIVE NEUROTRONICS INC. WALKAIDE SYSTEM 04/01/2013
K140886 INNOVATIVE NEUROTRONICS INC. WALKAIDE SYSTEM 08/08/2014
K052329 INNOVATIVE NEUROTRONICS INC. WALKAIDE SYSTEM, MODELS 20-0100, 20-0310, 20-1000 09/21/2005
K170564 MyndTec Inc MyndMove System, MyndMove Functional Electrical Stimulator 08/30/2017
K212149 MyndTec Inc. MyndMove 2.0 03/03/2022
K170132 MYOLYN, LLC MyoCycle Home, MyoCycle Pro 04/25/2017
K213925 Myolyn, LLC MyoCycle MC-2 (Home / Home + / Pro / Pro +) 04/25/2022
K031900 NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS HANDMASTER 08/08/2003
K012823 NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS MODIFICATION TO HANDMASTER 11/14/2001
K080219 NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS MODIFICATION TO:NESS L300 02/28/2008
K111767 NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT 09/15/2011
K053468 NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS NESS L300 07/07/2006
K974514 NEUROMOTION, INC. EXTERNAL FUNCTIONAL NEUROMUSCULAR STIMULATOR 02/06/1998
K010837 NEUROMUSCLAR ELECTRICAL STIMULATION SYSTEMS, LTD. HANDMASTER 06/15/2001
K102115 ODSTOCK MEDICAL LTD ODFS PACE 03/30/2011
K171396 Odstock Medical Ltd ODFS Pace XL 01/31/2018
K141812 OTTO BOCK HEALTHCARE PRODUCTS GMBH MYGAIT STIMULATION SYSTEM 04/02/2015
K153163 Rehabtronics Inc. ReGrasp 04/07/2016
K050036 RESTORATIVE THERAPIES INC. FES CYCLE ERGOMETER, MODEL RT300-S 06/27/2005
K103370 RESTORATIVE THERAPIES INC. RT200 04/05/2011
K072398 RESTORATIVE THERAPIES INC. RT300-S AND RT300-SP FES CYCLE ERGOMETER 11/21/2007
K071113 RESTORATIVE THERAPIES INC. RT300-S, MODEL FA100052, RT300-SP (PEDIATRIC VERSION), MODEL FA100053 07/05/2007
K060032 RESTORATIVE THERAPIES INC. RT300-S, MODEL FA100052; RT300-SP, MODEL FA100053 03/10/2006
K071486 RESTORATIVE THERAPIES INC. RT300-S, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, FA100053 09/10/2007
K090750 RESTORATIVE THERAPIES INC. RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581 08/05/2009
K103366 RESTORATIVE THERAPIES INC. RT600 04/04/2011
K162470 Restorative Therapies, Inc. RT300 FES cycle ergometer 07/11/2017
K162718 SHENZHEN XFT Medical Limited Foot Drop System (Model XFT-2001D) 11/30/2017
K193276 Shenzhen XFT Medical Limited Nerve and Muscle Stimulator 09/23/2020
K131923 TECHLINK INTERNATIONAL NEURODYN PORTABLE TENS NFES, NEURODYN PORTABLE TENS 07/03/2014


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