K242704 is an FDA 510(k) clearance for the Synchrony (20-3000). This device is classified as a Stimulator, Neuromuscular, External Functional (Class II - Special Controls, product code GZI).
Submitted by Synapse Biomedical, Inc. (Oberline, US). The FDA issued a Cleared decision on June 5, 2025, 269 days after receiving the submission on September 9, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5810.
| 510(k) Number | K242704 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 2024 |
| Decision Date | June 05, 2025 |
| Days to Decision | 269 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GZI - Stimulator, Neuromuscular, External Functional |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5810 |