Cleared Abbreviated

Quantum Mitohormesis (QMT) (M2101)

K240348 · Quantumtx Pte. , Ltd. · Physical Medicine

Dec 2024

Decision

318d

Days

Class 2

Risk

About This 510(k) Submission

K240348 is an FDA 510(k) clearance for the Quantum Mitohormesis (QMT) (M2101), 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 review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number	K240348 FDA.gov
FDA Decision	Cleared 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