K242704
- 510(k) number
- K242704
- Device name
- Synchrony (20-3000)
- Applicant
- Synapse Biomedical, Inc. OH · US
- Product code
- GZI — Stimulator, Neuromuscular, External Functional
- Decision date
- 2025-06-05
- Date received
- 2024-09-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K242704.pdf
Official FDA record: K242704
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.