GZI — Stimulator, Neuromuscular, External Functional Class II
FDA Device Classification
Classification Details
- Product Code
- GZI
- Device Class
- Class II
- Regulation Number
- 882.5810
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K242704 | synapse biomedical | Synchrony (20-3000) | June 5, 2025 |
| K243828 | cionic | CIONIC NEURAL SLEEVE (NS-200) | May 2, 2025 |
| K240632 | neuvotion | Neuvotion NeuStim NN-01 | November 22, 2024 |
| K233006 | myndtec | MyndMove, MyndMove 2.0 | June 25, 2024 |
| K230997 | evolution devices | EvoWalk 1.0 System | December 28, 2023 |
| K221823 | cionic | Cionic Neural Sleeve NS-100 | July 21, 2022 |
| K213925 | myolyn | MyoCycle MC-2 (Home / Home + / Pro / Pro +) | April 25, 2022 |
| K212149 | myndtec | MyndMove 2.0 | March 3, 2022 |
| K213622 | cionic | Cionic Neural Sleeve NS-100 | February 14, 2022 |
| K202110 | guangzhou longest science and technology co | MStim Drop Model: LGT-233 | November 5, 2021 |
| K193276 | shenzhen xft medical limited | Nerve and Muscle Stimulator | September 23, 2020 |
| K200262 | bioness | L100 Go System | March 4, 2020 |
| K191587 | bioness | L360 Thigh System | September 12, 2019 |
| K190285 | bioness | L300 Go System | March 14, 2019 |
| K173682 | bioness | L300 Go System | March 9, 2018 |
| K171396 | odstock medical | ODFS Pace XL | January 31, 2018 |
| K162718 | shenzhen xft medical limited | Foot Drop System (Model XFT-2001D) | November 30, 2017 |
| K170564 | myndtec | MyndMove System, MyndMove Functional Electrical Stimulator | August 30, 2017 |
| K162470 | restorative therapies | RT300 FES cycle ergometer | July 11, 2017 |
| K170132 | myolyn | MyoCycle Home, MyoCycle Pro | April 25, 2017 |