Product code GZI
- Device name
- Stimulator, Neuromuscular, External Functional
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.5810
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242704 | Synchrony (20-3000) | Synapse Biomedical, Inc. | 2025-06-05 |
| K243828 | CIONIC NEURAL SLEEVE (NS-200) | Cionic, Inc. | 2025-05-02 |
| K240632 | Neuvotion NeuStim NN-01 | Neuvotion, Inc. | 2024-11-22 |
| K233006 | MyndMove, MyndMove 2.0 | Myndtec, Inc. | 2024-06-25 |
| K230997 | EvoWalk 1.0 System | Evolution Devices, Inc. | 2023-12-28 |
| K221823 | Cionic Neural Sleeve NS-100 | Cionic | 2022-07-21 |
| K213925 | MyoCycle MC-2 (Home / Home + / Pro / Pro +) | Myolyn, LLC | 2022-04-25 |
| K212149 | MyndMove 2.0 | Myndtec, Inc. | 2022-03-03 |
| K213622 | Cionic Neural Sleeve NS-100 | Cionic | 2022-02-14 |
| K202110 | MStim Drop Model: LGT-233 | Guangzhou Longest Science & Technology Co., Ltd. | 2021-11-05 |
| K193276 | Nerve and Muscle Stimulator | Shenzhen Xft Medical Limited | 2020-09-23 |
| K200262 | L100 Go System | Bioness, Inc. | 2020-03-04 |
| K191587 | L360 Thigh System | Bioness, Inc. | 2019-09-12 |
| K190285 | L300 Go System | Bioness, Inc. | 2019-03-14 |
| K173682 | L300 Go System | Bioness, Inc. | 2018-03-09 |
| K171396 | ODFS Pace XL | Odstock Medical, Ltd. | 2018-01-31 |
| K162718 | Foot Drop System (Model XFT-2001D) | Shenzhen Xft Medical Limited | 2017-11-30 |
| K170564 | MyndMove System, MyndMove Functional Electrical Stimulator | Myndtec, Inc. | 2017-08-30 |
| K162470 | RT300 FES cycle ergometer | Restorative Therapies, Inc. | 2017-07-11 |
| K170132 | MyoCycle Home, MyoCycle Pro | Myolyn, LLC | 2017-04-25 |
| K162683 | RehaStim 2 | Hasomed GmbH | 2017-02-03 |
| K162407 | L300 Go System | Bioness, Inc. | 2017-01-27 |
| K153163 | ReGrasp | Rehabtronics, Inc. | 2016-04-07 |
| K141812 | MYGAIT STIMULATION SYSTEM | Otto Bock Healthcare Products GmbH | 2015-04-02 |
| K140886 | WALKAIDE SYSTEM | Innovative Neurotronics, Inc. | 2014-08-08 |
| K131923 | NEURODYN PORTABLE TENS NFES, NEURODYN PORTABLE TENS | Techlink International | 2014-07-03 |
| K132416 | REHASTIM 2, ERIGOPRO (FES) | Hasomed GmbH | 2014-05-28 |
| K123636 | H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE TRIGGERING DEVICE | Bioness, Inc. | 2013-05-01 |
| K123972 | WALKAIDE SYSTEM | Innovative Neurotronics, Inc. | 2013-04-01 |
| 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 17540176030253 | ReGrasp | Rehabtronics Inc | 2024-02-23 |
| 17540176030246 | ReGrasp | Rehabtronics Inc | 2024-02-23 |
| 17540176030239 | ReGrasp | Rehabtronics Inc | 2024-02-23 |
| 17540176030222 | ReGrasp | Rehabtronics Inc | 2024-02-23 |
| 17540176030215 | ReGrasp | Rehabtronics Inc | 2024-02-23 |
| 17540176030208 | ReGrasp | Rehabtronics Inc | 2024-02-23 |
| 17540176030192 | ReGrasp | Rehabtronics Inc | 2024-02-23 |
| 17540176030185 | ReGrasp | Rehabtronics Inc | 2024-02-23 |
| 17540176030178 | ReGrasp | Rehabtronics Inc | 2024-02-23 |
| 17540176030161 | ReGrasp | Rehabtronics Inc | 2024-02-23 |
| 17540176030154 | ReGrasp | Rehabtronics Inc | 2024-02-23 |
| G345NS1000 | CIONIC | Cionic, Inc. | 2022-12-15 |
| 07898961579115 | Ibramed | Ibramed Industria Brasileira de Equipamentos Medicos Eir | 2017-10-13 |
| 07898961579108 | Ibramed | Ibramed Industria Brasileira de Equipamentos Medicos Eir | 2017-10-13 |
| 07898961579054 | Ibramed | Ibramed Industria Brasileira de Equipamentos Medicos Eir | 2017-10-13 |
| 07898961579047 | Ibramed | Ibramed Industria Brasileira de Equipamentos Medicos Eir | 2017-10-13 |
| 07898961579030 | Ibramed | Ibramed Industria Brasileira de Equipamentos Medicos Eir | 2017-10-13 |
| 07898961579023 | Ibramed | Ibramed Industria Brasileira de Equipamentos Medicos Eir | 2017-10-13 |
| 17540176030055 | ReGrasp | Rehabtronics Inc | 2017-08-29 |
| 17540176030062 | ReGrasp | Rehabtronics Inc | 2017-08-29 |
| 17540176030079 | ReGrasp | Rehabtronics Inc | 2017-08-29 |
| 17540176030086 | ReGrasp | Rehabtronics Inc | 2017-08-29 |
| 17540176030093 | ReGrasp | Rehabtronics Inc | 2017-08-29 |
| 17540176030109 | ReGrasp | Rehabtronics Inc | 2017-08-29 |
| 17540176030048 | ReGrasp | Rehabtronics Inc | 2017-08-29 |
| 17540176030000 | ReGrasp | Rehabtronics Inc | 2017-08-29 |
| 07898961579016 | Ibramed | Ibramed Industria Brasileira de Equipamentos Medicos Eir | 2017-03-17 |
| B36711001L00 | EMPI Focus 2 Channel Stimulator | AXIOBIONICS | 2016-09-24 |
| B3671100300 | Axio 4 Channel Stimulator | AXIOBIONICS | 2016-09-24 |
| 07629999033894 | Erigo | HOCOMA AG | 2016-03-11 |