K230997
- 510(k) number
- K230997
- Device name
- EvoWalk 1.0 System
- Applicant
- Evolution Devices, Inc. CA · US
- Product code
- GZI — Stimulator, Neuromuscular, External Functional
- Decision date
- 2023-12-28
- Date received
- 2023-04-07
- 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: K230997.pdf
Official FDA record: K230997
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.