DEN230051 is an FDA 510(k) submission for the Myocene. This device is classified as a Neuromuscular Stimulator And Exercise Evaluation System (Class II - Special Controls, product code SDX).
Submitted by Myocene (Liège, BE). The FDA issued a Not Cleared (DENG) decision on January 17, 2025.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 882.1871. A Neuromuscular Stimulator And Evaluation System Is A Device That Applies Neuromuscular Stimulation And Measures A Neuromuscular Response, For The Purpose Of Evaluating Exercise Capacity And Performance Or Informing Athletic Training Decisions..
| 510(k) Number | DEN230051 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | July 27, 2023 |
| Decision Date | January 17, 2025 |
| Days to Decision | 540 days |
| Submission Type | Direct |
| Review Panel | Physical Medicine (PM) |
| Summary | - |
| Product Code | SDX - Neuromuscular Stimulator And Exercise Evaluation System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1871 |
| Definition | A Neuromuscular Stimulator And Evaluation System Is A Device That Applies Neuromuscular Stimulation And Measures A Neuromuscular Response, For The Purpose Of Evaluating Exercise Capacity And Performance Or Informing Athletic Training Decisions. |