K240992 is an FDA 510(k) clearance for the eMVFit (MVF-10M). 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 October 10, 2024, 182 days after receiving the submission on April 11, 2024.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K240992 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 11, 2024 |
| Decision Date | October 10, 2024 |
| Days to Decision | 182 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IPF — Stimulator, Muscle, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5850 |