Stimulator, Neuromuscular, External Functional
Regulation 882.5810
0510(k)s in 12 months (61 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in GZI
| Company | 510(k)s | Recalls |
|---|---|---|
| Bioness, Inc. | 9 | 0 |
| Restorative Therapies, Inc. | 9 | 0 |
| Ness-Neuromuscular Electrical Stimulation Systems | 5 | 0 |
| Hasomed GmbH | 4 | 0 |
| Innovative Neurotronics, Inc. | 3 | 1 |
| Cionic | 3 | 0 |
| Myndtec, Inc. | 3 | 0 |
| Myolyn, LLC | 2 | 1 |
| Odstock Medical, Ltd. | 2 | 0 |
| Shenzhen Xft Medical Limited | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 5, 2025 | K242704 | Synchrony (20-3000) Synapse Biomedical, Inc. | GZI |
| May 2, 2025 | K243828 | CIONIC NEURAL SLEEVE (NS-200) Cionic, Inc. | GZI |
| Nov 22, 2024 | K240632 | Neuvotion NeuStim NN-01 Neuvotion, Inc. | GZI |
| Jun 25, 2024 | K233006 | MyndMove, MyndMove 2.0 Myndtec, Inc., CA | GZI |
| Dec 28, 2023 | K230997 | EvoWalk 1.0 System Evolution Devices, Inc. | GZI |
| Jul 21, 2022 | K221823 | Cionic Neural Sleeve NS-100 Cionic | GZI |
| Apr 25, 2022 | K213925 | MyoCycle MC-2 (Home / Home + / Pro / Pro +) Myolyn, LLC | GZI |
| Mar 3, 2022 | K212149 | MyndMove 2.0 Myndtec, Inc., CA | GZI |
| Feb 14, 2022 | K213622 | Cionic Neural Sleeve NS-100 Cionic | GZI |
| Nov 5, 2021 | K202110 | MStim Drop Model: LGT-233 Guangzhou Longest Science & Technology Co., Ltd., CN | GZI |
| Sep 23, 2020 | K193276 | Nerve and Muscle Stimulator Shenzhen Xft Medical Limited, CN | GZI |
| Mar 4, 2020 | K200262 | L100 Go System Bioness, Inc. | GZI |
| Sep 12, 2019 | K191587 | L360 Thigh System Bioness, Inc. | GZI |
| Mar 14, 2019 | K190285 | L300 Go System Bioness, Inc. | GZI |
| Mar 9, 2018 | K173682 | L300 Go System Bioness, Inc. | GZI |
| Jan 31, 2018 | K171396 | ODFS Pace XL Odstock Medical, Ltd., GB | GZI |
| Nov 30, 2017 | K162718 | Foot Drop System (Model XFT-2001D) Shenzhen Xft Medical Limited, CN | GZI |
| Aug 30, 2017 | K170564 | MyndMove System, MyndMove Functional Electrical Stimulator Myndtec, Inc., CA | GZI |
| Jul 11, 2017 | K162470 | RT300 FES cycle ergometer Restorative Therapies, Inc. | GZI |
| Apr 25, 2017 | K170132 | MyoCycle Home, MyoCycle Pro Myolyn, LLC | GZI |
| Feb 3, 2017 | K162683 | RehaStim 2 Hasomed GmbH, DE | GZI |
| Jan 27, 2017 | K162407 | L300 Go System Bioness, Inc. | GZI |
| Apr 7, 2016 | K153163 | ReGrasp Rehabtronics, Inc., CA | GZI |
| Apr 2, 2015 | K141812 | MYGAIT STIMULATION SYSTEM Otto Bock Healthcare Products GmbH, AT | GZI |
| Aug 8, 2014 | K140886 | WALKAIDE SYSTEM Innovative Neurotronics, Inc. | GZI |
| Jul 3, 2014 | K131923 | NEURODYN PORTABLE TENS NFES, NEURODYN PORTABLE TENS Techlink International | GZI |
| May 28, 2014 | K132416 | REHASTIM 2, ERIGOPRO (FES) Hasomed GmbH, DE | GZI |
| May 1, 2013 | K123636 | H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE TRIGGERING DEVICE Bioness, Inc. | GZI |
| Apr 1, 2013 | K123972 | WALKAIDE SYSTEM Innovative Neurotronics, Inc. | GZI |
| Dec 27, 2012 | 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. | GZI |
| Apr 20, 2012 | K120853 | NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, Bioness, Inc. | GZI |
| Oct 27, 2011 | K112844 | REHASTIM 2, REHAMOVE 2 Hasomed GmbH, DE | GZI |
| Sep 15, 2011 | K111767 | NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT Ness-Neuromuscular Electrical Stimulation Systems, IL | GZI |
| Apr 29, 2011 | K103343 | L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT) Bioness, Inc. | GZI |
| Apr 5, 2011 | K103370 | RT200 Restorative Therapies, Inc. | GZI |
| Apr 4, 2011 | K103366 | RT600 Restorative Therapies, Inc. | GZI |
| Mar 30, 2011 | K102115 | ODFS PACE Odstock Medical, Ltd., GB | GZI |
| Aug 5, 2009 | K090750 | RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581 Restorative Therapies, Inc. | GZI |
| Feb 28, 2008 | K080219 | MODIFICATION TO:NESS L300 Ness-Neuromuscular Electrical Stimulation Systems | GZI |
| Dec 27, 2007 | K073237 | REHASTIM & REHAMOVE Hasomed GmbH, DE | GZI |
| Nov 21, 2007 | K072398 | RT300-S AND RT300-SP FES CYCLE ERGOMETER Restorative Therapies, Inc. | GZI |
| Sep 10, 2007 | K071486 | RT300-S, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, FA100053 Restorative Therapies, Inc. | GZI |
| Jul 5, 2007 | K071113 | RT300-S, MODEL FA100052, RT300-SP (PEDIATRIC VERSION), MODEL FA100053 Restorative Therapies, Inc. | GZI |
| Jul 7, 2006 | K053468 | NESS L300 Ness-Neuromuscular Electrical Stimulation Systems | GZI |
| Mar 10, 2006 | K060032 | RT300-S, MODEL FA100052; RT300-SP, MODEL FA100053 Restorative Therapies, Inc. | GZI |
| Sep 21, 2005 | K052329 | WALKAIDE SYSTEM, MODELS 20-0100, 20-0310, 20-1000 Innovative Neurotronics, Inc. | GZI |
| Jul 15, 2005 | K050991 | THE ODFS DROPPED FOOT STIMULATOR Department of Medical Physics and Biomedical Eng. | GZI |
| Jun 27, 2005 | K050036 | FES CYCLE ERGOMETER, MODEL RT300-S Restorative Therapies, Inc. | GZI |
| Aug 8, 2003 | K031900 | HANDMASTER Ness-Neuromuscular Electrical Stimulation Systems | GZI |
| Nov 14, 2001 | K012823 | MODIFICATION TO HANDMASTER Ness-Neuromuscular Electrical Stimulation Systems | GZI |
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