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 |
| K243828 | CIONIC Inc. | CIONIC NEURAL SLEEVE (NS-200) | 05/02/2025 |
| K050991 | DEPARTMENT OF MEDICAL PHYSICS AND BIOMEDICAL ENG. | THE ODFS DROPPED FOOT STIMULATOR | 07/15/2005 |
| K230997 | Evolution Devices, Inc. | EvoWalk 1.0 System | 12/28/2023 |
| 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 |
| K233006 | MyndTec Inc. | MyndMove, MyndMove 2.0 | 06/25/2024 |
| 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 |
| K240632 | Neuvotion Inc. | Neuvotion NeuStim NN-01 | 11/22/2024 |
| 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 |
| K242704 | Synapse Biomedical, Inc. | Synchrony (20-3000) | 06/05/2025 |
| K131923 | TECHLINK INTERNATIONAL | NEURODYN PORTABLE TENS NFES, NEURODYN PORTABLE TENS | 07/03/2014 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
