The following data is part of a premarket notification filed by Cionic with the FDA for Cionic Neural Sleeve Ns-100.
| Device ID | K221823 |
| 510k Number | K221823 |
| Device Name: | Cionic Neural Sleeve NS-100 |
| Classification | Stimulator, Neuromuscular, External Functional |
| Applicant | CIONIC 1606 Stockton St, Suite #1 San Francisco, CA 94133 |
| Contact | Mihai Ionescu |
| Correspondent | Mihai Ionescu CIONIC 1606 Stockton St, Suite #1 San Francisco, CA 94133 |
| Product Code | GZI |
| CFR Regulation Number | 882.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-23 |
| Decision Date | 2022-07-21 |