K241433 is an FDA 510(k) clearance for the EVE Synergy (EVE-20M). This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).
Submitted by Weero Co., Ltd. (Suwon, KR). The FDA issued a Cleared decision on June 4, 2025, 379 days after receiving the submission on May 21, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K241433 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 21, 2024 |
| Decision Date | June 04, 2025 |
| Days to Decision | 379 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | IPF — Stimulator, Muscle, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5850 |