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LOREM X RP-PEMF = Safe

01    Safety of Conventional PEMF

Conventional PEMF is already very safe.

The US FDA has been monitoring medical-grade PEMF devices since the 1970s and now considers them low-risk

The FDA has a guide, "General Wellness: Policy for Low Risk Devices," that outlines when the agency generally does not actively regulate low-risk devices and considers them general wellness products.

Today, PEMF devices can be marketed in the United States as either wellness devices (without medical claims) or medical devices (with medical claims).

TMS can only be sold in the US as a Medical Device.

02    Safety of our patent-pending, RP-PEMF technology.

The safety of the LOREM X RP-PEMF System stems from its innovative engineering approach to developing a Safe RP-PEMF method in general, and, more specifically, a Safe RP-PEMF Wellness modality.

RP-PEMF uses:

  • Weak, Sparse, short pulses with long inter-pulse rests. Eliminating risks for arousal, summation, and wind-up.

  • In comparison with already proven, safe conventional PEMF, RP-PEMF has:

    • Lower frequencies, with shorter and weaker pulses (safer)

    • low energy transfer (low Duty Cycle) (safer)

  • Low-voltage operation: 24 V

    • Unlike many commercial (high-dB/dt) PEMF systems that operate at hundreds or even thousands of volts, the LOREM X system operates at very low voltages (12-24V).

    • This fundamentally minimizes the risks of electrical shock, dielectric breakdown, leakage currents, and thermal hazards.

  • Minimized Electromagnetic Interference (EMI):

    • The Lorem X RP-PEMF hardware avoids high-voltage-capacitor discharge systems and relies on a low-impedance output stage with optimized loss suppression, thereby inherently generating ultra-low EMI.

    • Measured EMI emissions are significantly below allowable limits, demonstrating exceptional electromagnetic cleanliness. This is crucial for user and bystander safety. LOREM X RP-PEMF is tested and certified to international EMC standards (e.g., IEC 60335-1, EN 62233, CISPR 14-1:2020, IEC 61000-3-2:2018, IEC 61000-3-2:2018/AMD1:2020, IEC 61000-3-2:2018/AMD2:202, IEC 61000-3-3:2013, IEC 61000-3-3:2013/AMD1:2017, IEC 61000-3-3:2013/AMD2:2021).

    • In contrast, many conventional high-dB/dt PEMFT systems produce fast transitions using high voltages, generating broadband EMI that complicates certification and device coexistence.

    • LOREM X RP-PEMF includes a dedicated ringing-suppression design that reduces high-frequency transients in the 1–10 MHz range. Although the system passed international compliance testing without this suppression, we chose to add it anyway to further minimize the residual ringing that can occur with fast-switching (square-like) waveforms.

  • Reduced Thermal Risk and No Energy Dumping:

    • The LOREN X RP-PEMF system's design avoids the high-voltage energy dumps common in conventional high-dB/dt systems, which can lead to overheating and thermal inefficiency.

    • All RP-PEMF protocols use long rest intervals between pulses, evading any thermal effects.

  • Tested and certified for household electrical safety and electromagnetic compatibility

 

 

​LOREM X RP-PEMF Wellness system is designed for repeated wellness sessions with ongoing comfort, without jolts or painful pulses going through the body.

 

LOREM X RP-PEMF wellness is safer compared to conventional PEMF because it doesn’t rely on high drive.
It uses controlled, low-intensity pulses and long rest intervals to keep stimulation conservative, predictable, and free of unnecessary cumulative build-up (summation and wind-up).

03    Concerning safety, long rest intervals go a long way

Low magnetic stimulation is important for both PR-PEMF Wellness modality and RP-PEMF Safety in general.

But Long rest intervals are crucial for RP-PEMF safety; they prevent cumulative build-up, and help keep RP-PEMF sessions calm, controlled, and safety-oriented. 

MACMED SA de CV, Puerto Escondido, Mexico
RP-PEMF Wellness

Calle 5 Sur 211

71983 Puerto Escondido

OAX, Mexico
Tel: +52 9545822951

 

Lorem X RP-PEMF Wellness intended use: to promote a relaxing experience, for adult wellness use only.

LOREM X RP-PEMF Wellness is not a medical device.

Lorem X does not intend, directly or indirectly, to be used in human beings; with one or more of the following purposes of use:

• Diagnosis, prevention, surveillance or monitoring, and/or assistance in the treatment of diseases;

• Diagnosis, surveillance or monitoring, treatment, protection, absorption, drainage, or assistance in the healing of an injury;

• Replacement, modification, or support of the anatomy or of a physiological process.

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