510(k) K240348

Quantum Mitohormesis (QMT) (M2101) by Quantumtx Pte. , Ltd. — Product Code IPF

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