Cionic Neural Sleeve NS-100
by Cionic 2 variants
510(k) K213622
Cionic Neural Sleeve NS-100 is a Class II device made by Cionic, cleared under FDA 510(k) K213622 on 14 Feb 2022, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK213622 | Date14 Feb 2022 | StatusActive |
Official records
- FDA 510(k) database K213622
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GZI
- Device class
- Class II
- Regulation
- 21 CFR Part 882.5810
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
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