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    K Number
    K240348
    Device Name
    Quantum Mitohormesis (QMT) (M2101)
    Manufacturer
    QuantumTX Pte. Ltd.
    Date Cleared
    2024-12-19

    (318 days)

    Product Code
    IPF, NGX
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    QuantumTX Pte. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Quantum Mitohormesis Medical Device is intended for: - Stimulating healthy limb muscles to improve and facilitate muscle performance. - Preventing or retardation of disuse atrophy of muscles.
    Device Description
    Quantum Mitohormesis (QMT) is a medical device that uses unique pulsed electromagnetic fields for muscle therapy. Users (adults ≥ 22 years old) place one group of muscles in the lower limbs into the field applicator of QMT device, which for a defined duration generates specific electromagnetic fields that stimulates healthy muscles to improve and facilitate muscle performance, and prevents and retards muscle disuse atrophy. QMT is applied directly to muscles (without direct contact) to stimulate muscle activity. In order to achieve optimized treatment outcome, QMT is applied to muscles on a weekly basis, once or twice a week, with each treatment application lasting a brief 10-minutes. The device consists of the following high-level components: - Base unit, which includes signal generator, power amplifier, and micro-controller unit. - Field applicator, which includes electro-magnetic coils generating specific magnetic pulses. - User Interface Panel, which allows users to operate the device and display necessary device information. - Signal cord. - Height and tilt adjustment knobs, which allow users to adjust the height and tilt of field applicator; and
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