510(k) K240348
K240348 is an FDA 510(k) premarket notification submitted by Quantumtx Pte. , Ltd. for the device "Quantum Mitohormesis (QMT) (M2101)". The FDA issued a decision of Substantially Equivalent on December 19, 2024. 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
- December 19, 2024
- Date Received
- February 5, 2024
- Clearance Type
- Abbreviated
- 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