K243828 is an FDA 510(k) clearance for the CIONIC NEURAL SLEEVE (NS-200). This device is classified as a Stimulator, Neuromuscular, External Functional (Class II - Special Controls, product code GZI).
Submitted by Cionic, Inc. (Scotts Valley, US). The FDA issued a Cleared decision on May 2, 2025, 140 days after receiving the submission on December 13, 2024.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 882.5810.
| 510(k) Number | K243828 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 2024 |
| Decision Date | May 02, 2025 |
| Days to Decision | 140 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | GZI - Stimulator, Neuromuscular, External Functional |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5810 |