K243828
- 510(k) number
- K243828
- Device name
- CIONIC NEURAL SLEEVE (NS-200)
- Applicant
- Cionic, Inc. CA · US
- Product code
- GZI — Stimulator, Neuromuscular, External Functional
- Decision date
- 2025-05-02
- Date received
- 2024-12-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K243828.pdf
Official FDA record: K243828
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.