FDA Product Code
FDA Product Code GZI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.5810
510(k) Clearances — 61 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K242704 | Synchrony (20-3000) | Synapse Biomedical, Inc. | 2025-06-05 | Traditional | PDF ↗ |
| K243828 | CIONIC NEURAL SLEEVE (NS-200) | Cionic, Inc. | 2025-05-02 | Traditional | PDF ↗ |
| K240632 | Neuvotion NeuStim NN-01 | Neuvotion, Inc. | 2024-11-22 | Traditional | PDF ↗ |
| K233006 | MyndMove, MyndMove 2.0 | Myndtec, Inc. | 2024-06-25 | Traditional | PDF ↗ |
| K230997 | EvoWalk 1.0 System | Evolution Devices, Inc. | 2023-12-28 | Traditional | PDF ↗ |
| K221823 | Cionic Neural Sleeve NS-100 | Cionic | 2022-07-21 | Special | PDF ↗ |
| K213925 | MyoCycle MC-2 (Home / Home + / Pro / Pro +) | Myolyn, LLC | 2022-04-25 | Traditional | PDF ↗ |
| K212149 | MyndMove 2.0 | Myndtec, Inc. | 2022-03-03 | Traditional | PDF ↗ |
| K213622 | Cionic Neural Sleeve NS-100 | Cionic | 2022-02-14 | Traditional | PDF ↗ |
| K202110 | MStim Drop Model: LGT-233 | Guangzhou Longest Science & Technology Co., Ltd. | 2021-11-05 | Traditional | PDF ↗ |
| K193276 | Nerve and Muscle Stimulator | Shenzhen Xft Medical Limited | 2020-09-23 | Traditional | PDF ↗ |
| K200262 | L100 Go System | Bioness, Inc. | 2020-03-04 | Special | PDF ↗ |
| K191587 | L360 Thigh System | Bioness, Inc. | 2019-09-12 | Traditional | PDF ↗ |
| K190285 | L300 Go System | Bioness, Inc. | 2019-03-14 | Special | PDF ↗ |
| K173682 | L300 Go System | Bioness, Inc. | 2018-03-09 | Traditional | PDF ↗ |
| K171396 | ODFS Pace XL | Odstock Medical, Ltd. | 2018-01-31 | Traditional | PDF ↗ |
| K162718 | Foot Drop System (Model XFT-2001D) | Shenzhen Xft Medical Limited | 2017-11-30 | Traditional | PDF ↗ |
| K170564 | MyndMove System, MyndMove Functional Electrical Stimulator | Myndtec, Inc. | 2017-08-30 | Traditional | PDF ↗ |
| K162470 | RT300 FES cycle ergometer | Restorative Therapies, Inc. | 2017-07-11 | Traditional | PDF ↗ |
| K170132 | MyoCycle Home, MyoCycle Pro | Myolyn, LLC | 2017-04-25 | Traditional | PDF ↗ |
| K162683 | RehaStim 2 | Hasomed GmbH | 2017-02-03 | Traditional | PDF ↗ |
| K162407 | L300 Go System | Bioness, Inc. | 2017-01-27 | Traditional | PDF ↗ |
| K153163 | ReGrasp | Rehabtronics, Inc. | 2016-04-07 | Traditional | PDF ↗ |
| K141812 | MYGAIT STIMULATION SYSTEM | Otto Bock Healthcare Products GmbH | 2015-04-02 | Traditional | PDF ↗ |
| K140886 | WALKAIDE SYSTEM | Innovative Neurotronics, Inc. | 2014-08-08 | Traditional | PDF ↗ |
| K131923 | NEURODYN PORTABLE TENS NFES, NEURODYN PORTABLE TENS | Techlink International | 2014-07-03 | Traditional | PDF ↗ |
| K132416 | REHASTIM 2, ERIGOPRO (FES) | Hasomed GmbH | 2014-05-28 | Traditional | PDF ↗ |
| K123636 | H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE TRIGGERING DEVICE | Bioness, Inc. | 2013-05-01 | Traditional | PDF ↗ |
| K123972 | WALKAIDE SYSTEM | Innovative Neurotronics, Inc. | 2013-04-01 | Traditional | PDF ↗ |
| K122784 | NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM KIT, RIGHT MODEL LG3-5000; SMALL NESS L300 SYSTEM KIT, RIGHT | Bioness, Inc. | 2012-12-27 | Traditional | PDF ↗ |
| K120853 | NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, | Bioness, Inc. | 2012-04-20 | Special | PDF ↗ |
| K112844 | REHASTIM 2, REHAMOVE 2 | Hasomed GmbH | 2011-10-27 | Special | PDF ↗ |
| K111767 | NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT | Ness-Neuromuscular Electrical Stimulation Systems | 2011-09-15 | Traditional | PDF ↗ |
| K103343 | L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT) | Bioness, Inc. | 2011-04-29 | Traditional | PDF ↗ |
| K103370 | RT200 | Restorative Therapies, Inc. | 2011-04-05 | Traditional | PDF ↗ |
| K103366 | RT600 | Restorative Therapies, Inc. | 2011-04-04 | Traditional | PDF ↗ |
| K102115 | ODFS PACE | Odstock Medical, Ltd. | 2011-03-30 | Traditional | PDF ↗ |
| K090750 | RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581 | Restorative Therapies, Inc. | 2009-08-05 | Traditional | PDF ↗ |
| K080219 | MODIFICATION TO:NESS L300 | Ness-Neuromuscular Electrical Stimulation Systems | 2008-02-28 | Special | PDF ↗ |
| K073237 | REHASTIM & REHAMOVE | Hasomed GmbH | 2007-12-27 | Traditional | PDF ↗ |
| K072398 | RT300-S AND RT300-SP FES CYCLE ERGOMETER | Restorative Therapies, Inc. | 2007-11-21 | Traditional | PDF ↗ |
| K071486 | RT300-S, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, FA100053 | Restorative Therapies, Inc. | 2007-09-10 | Special | PDF ↗ |
| K071113 | RT300-S, MODEL FA100052, RT300-SP (PEDIATRIC VERSION), MODEL FA100053 | Restorative Therapies, Inc. | 2007-07-05 | Traditional | PDF ↗ |
| K053468 | NESS L300 | Ness-Neuromuscular Electrical Stimulation Systems | 2006-07-07 | Traditional | PDF ↗ |
| K060032 | RT300-S, MODEL FA100052; RT300-SP, MODEL FA100053 | Restorative Therapies, Inc. | 2006-03-10 | Special | PDF ↗ |
| K052329 | WALKAIDE SYSTEM, MODELS 20-0100, 20-0310, 20-1000 | Innovative Neurotronics, Inc. | 2005-09-21 | Special | PDF ↗ |
| K050991 | THE ODFS DROPPED FOOT STIMULATOR | Department of Medical Physics and Biomedical Eng. | 2005-07-15 | Traditional | PDF ↗ |
| K050036 | FES CYCLE ERGOMETER, MODEL RT300-S | Restorative Therapies, Inc. | 2005-06-27 | Abbreviated | PDF ↗ |
| K031900 | HANDMASTER | Ness-Neuromuscular Electrical Stimulation Systems | 2003-08-08 | Special | PDF ↗ |
| K012823 | MODIFICATION TO HANDMASTER | Ness-Neuromuscular Electrical Stimulation Systems | 2001-11-14 | Traditional | PDF ↗ |
| K010837 | HANDMASTER | Neuromusclar Electrical Stimulation Systems, Ltd. | 2001-06-15 | Traditional | PDF ↗ |
| K974514 | EXTERNAL FUNCTIONAL NEUROMUSCULAR STIMULATOR | Neuromotion, Inc. | 1998-02-06 | Traditional | PDF ↗ |
| K940759 | FORTE ES | Chattanooga Group, Inc. | 1995-03-16 | Traditional | PDF ↗ |
| K911066 | COMFORTRON PT (TENS) | M. D. Supply, Inc. | 1992-02-07 | Traditional | PDF ↗ |
| K912615 | ROCHE COBAS ARGOS 5 DIFF | Roche Diagnostic Systems, Inc. | 1991-09-27 | Traditional | PDF ↗ |
| K903434 | SELECT NEUROMUSCULAR STIMULATORS | Medtronic Vascular | 1991-08-09 | Traditional | PDF ↗ |
| K873608 | TENS LEAD | Desco Industries, Inc. | 1987-09-30 | Traditional | PDF ↗ |
| K813515 | VERI/DFS TM #817 | Verite | 1982-01-19 | Traditional | PDF ↗ |
| K800380 | FES ORTHOSIS MODEL NO. 2000 | Empi | 1980-03-17 | Traditional | PDF ↗ |
| K770987 | NERVE STIMULATOR, MOLEL NO. FB-800 | Output, Inc. | 1977-06-14 | Traditional | PDF ↗ |
| K770725 | STIMULATOR, MUSCLE, MODEL 107 | Jaytronics, Inc. | 1977-04-26 | Traditional | PDF ↗ |
Product code GZI · Class II · Neurology. Data: openFDA.