510(k) K241488
K241488 is an FDA 510(k) premarket notification submitted by Trainfes for the device "TrainFES Advance". The FDA issued a decision of Substantially Equivalent on February 5, 2025. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 5, 2025
- Date Received
- May 24, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Muscle, Powered
- Device Class
- Class II
- Regulation Number
- 890.5850
- Review Panel
- PM
- Submission Type