K240348 is an FDA 510(k) clearance for the Quantum Mitohormesis (QMT) (M2101). This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).
Submitted by Quantumtx Pte. , Ltd. (Singapore, SG). The FDA issued a Cleared decision on December 19, 2024, 318 days after receiving the submission on February 5, 2024.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K240348 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 05, 2024 |
| Decision Date | December 19, 2024 |
| Days to Decision | 318 days |
| Submission Type | Abbreviated |
| 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 |