Quantum Mitohormesis (QMT) (M2101)

The Quantum Mitohormesis (QMT) is a non-invasive medical device that uses pulsed electromagnetic fields to stimulate healthy muscles in the lower limbs. It is intended to improve muscle performance and prevent or slow muscle atrophy from disuse. Treatment involves placing muscles in the device's field applicator for 10 minutes, once or twice weekly.

The QMT operates at 3.3 kHz pulse repetition rate with 150 microsecond pulse duration and 1.0–1.3 mT magnetic field amplitude using three coils in the applicator. This differs from predicate devices: the MAGNETOLITH uses 1–10 Hz at 0.4 T, while BEMER Classic & Pro uses 10–30 Hz at 35–100 µT. All devices use magnetic field induction for non-invasive tissue stimulation and are Class II devices powered by 100–240 VAC.

Biocompatibility per ISO 10993-1; electrical safety per IEC 60601-1 and IEC 60601-1-2; electromagnetic immunity per IEC TR 60601-4-2; usability per IEC 60601-1-6; and software verification/validation per IEC 62304. The device meets design control, labeling, and manufacturing requirements under 21 CFR 820.

The QMT shares the same regulatory classification (Class II), product codes (IPF, NGX), and principle of action (magnetic field induction for muscle stimulation) as both predicates. Although the QMT's magnetic pulse characteristics differ substantially (3.3 kHz vs. 1–10 Hz or 10–30 Hz), the submission argues these differences do not raise new safety or effectiveness issues because non-clinical testing—including biocompatibility, electrical safety, electromagnetic compatibility, and software validation—demonstrates the device meets all applicable standards. The intended use (stimulating healthy muscles, preventing disuse atrophy) overlaps with predicate indications, and risk assessments confirm no new hazards emerge from the design variations.