K221823 is an FDA 510(k) clearance for the Cionic Neural Sleeve NS-100. This device is classified as a Stimulator, Neuromuscular, External Functional (Class II - Special Controls, product code GZI).
Submitted by Cionic (San Francisco, US). The FDA issued a Cleared decision on July 21, 2022, 28 days after receiving the submission on June 23, 2022.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 882.5810.
| 510(k) Number | K221823 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 23, 2022 |
| Decision Date | July 21, 2022 |
| Days to Decision | 28 days |
| Submission Type | Special |
| 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 |