GZI — Stimulator, Neuromuscular, External Functional Class II
FDA product code GZI covers "Stimulator, Neuromuscular, External Functional", a Class II medical device regulated under 21 CFR 882.5810. Submissions are reviewed by the Neurology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |