K232334 is an FDA 510(k) clearance for the DEKA SIMON. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).
Submitted by El.En S.P.A. (Calenzano, IT). The FDA issued a Cleared decision on September 1, 2023, 28 days after receiving the submission on August 4, 2023.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K232334 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 2023 |
| Decision Date | September 01, 2023 |
| Days to Decision | 28 days |
| Submission Type | Special |
| 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 |