510(k) DEN230051
DEN230051 is an FDA 510(k) premarket notification submitted by Myocene for the device "Myocene". The FDA issued a decision of De Novo Granted on January 17, 2025. The device falls under product code SDX (Neuromuscular Stimulator And Exercise Evaluation System), a Class II device regulated under 21 CFR 882.1871.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- January 17, 2025
- Date Received
- July 27, 2023
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Neuromuscular Stimulator And Exercise Evaluation System
- Device Class
- Class II
- Regulation Number
- 882.1871
- Review Panel
- NE
- Submission Type
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.