GZI
- Product code
- GZI
- Device name
- Stimulator, Neuromuscular, External Functional
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.5810
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 5
- Summaries archived here
- 5 (direct download)
- 510(k) clearances (all years, FDA)
- 61 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (5)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K242704 | 2025-06-05 | Synapse Biomedical, Inc. | Synchrony (20-3000) | |
| K243828 | 2025-05-02 | Cionic, Inc. | CIONIC NEURAL SLEEVE (NS-200) | |
| K240632 | 2024-11-22 | Neuvotion, Inc. | Neuvotion NeuStim NN-01 | |
| K233006 | 2024-06-25 | Myndtec, Inc. | MyndMove, MyndMove 2.0 | |
| K230997 | 2023-12-28 | Evolution Devices, Inc. | EvoWalk 1.0 System |
Official FDA classification page: GZI
Classification and pathway per current FDA publications. Data from openFDA (CC0).