GZI · Stimulator, Neuromuscular, External Functional
Neurology · 21 CFR 882.5810 · Class 2
Overview
| Product Code | GZI |
|---|---|
| Device Name | Stimulator, Neuromuscular, External Functional |
| Regulation | 21 CFR 882.5810 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 3rd-Party Reviewable | Yes |
Identification
An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 61)
Showing 20 most recent of 61 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K242704 | Synchrony (20-3000) | Synapse Biomedical, Inc. | Jun 5, 2025 | SESE |
| K243828 | CIONIC NEURAL SLEEVE (NS-200) | Cionic, Inc. | May 2, 2025 | SESE |
| K240632 | Neuvotion NeuStim NN-01 | Neuvotion, Inc. | Nov 22, 2024 | SESE |
| K233006 | MyndMove, MyndMove 2.0 | Myndtec, Inc. | Jun 25, 2024 | SESE |
| K230997 | EvoWalk 1.0 System | Evolution Devices, Inc. | Dec 28, 2023 | SESE |
| K221823 | Cionic Neural Sleeve NS-100 | Cionic | Jul 21, 2022 | SESE |
| K213925 | MyoCycle MC-2 (Home / Home + / Pro / Pro +) | Myolyn, LLC | Apr 25, 2022 | SESE |
| K212149 | MyndMove 2.0 | Myndtec, Inc. | Mar 3, 2022 | SESE |
| K213622 | Cionic Neural Sleeve NS-100 | Cionic | Feb 14, 2022 | SESE |
| K202110 | MStim Drop Model: LGT-233 | Guangzhou Longest Science & Technology Co., Ltd. | Nov 5, 2021 | SESE |
| K193276 | Nerve and Muscle Stimulator | Shenzhen Xft Medical Limited | Sep 23, 2020 | SESE |
| K200262 | L100 Go System | Bioness, Inc. | Mar 4, 2020 | SESE |
| K191587 | L360 Thigh System | Bioness, Inc. | Sep 12, 2019 | SESE |
| K190285 | L300 Go System | Bioness, Inc. | Mar 14, 2019 | SESE |
| K173682 | L300 Go System | Bioness, Inc. | Mar 9, 2018 | SESE |
| K171396 | ODFS Pace XL | Odstock Medical, Ltd. | Jan 31, 2018 | SESE |
| K162718 | Foot Drop System (Model XFT-2001D) | Shenzhen Xft Medical Limited | Nov 30, 2017 | SESE |
| K170564 | MyndMove System, MyndMove Functional Electrical Stimulator | Myndtec, Inc. | Aug 30, 2017 | SESE |
| K162470 | RT300 FES cycle ergometer | Restorative Therapies, Inc. | Jul 11, 2017 | SESE |
| K170132 | MyoCycle Home, MyoCycle Pro | Myolyn, LLC | Apr 25, 2017 | SESE |
Top Applicants
- Bioness, Inc. — 9 clearances
- Restorative Therapies, Inc. — 9 clearances
- Ness-Neuromuscular Electrical Stimulation Systems — 5 clearances
- Hasomed GmbH — 4 clearances
- Innovative Neurotronics, Inc. — 3 clearances
