iTeraCare Second Degree Burn Testimonial
06/03/2025
Partner, Prife International
No. iTeraCare devices are not FDA-approved medical devices. They are sold as household wellness appliances, not as medical equipment, so they do not go through the FDA approval process that medicines and medical devices require. Any seller claiming “FDA approved” is misinformed. Here is what iTeraCare’s classification actually means and which certifications the devices do hold.
The U.S. Food and Drug Administration approves medical products that make medical claims: devices intended to diagnose, treat or prevent disease. iTeraCare is manufactured and marketed as a wellness appliance — like a massage gun or an infrared sauna blanket — so it sits outside that pathway. That is not a loophole or a scandal; it is simply a different product category with different rules: wellness devices must be electrically safe, but they may not claim to cure anything.
Terahertz radiation is not harmful to humans at low powers. It is a type of non-ionizing radiation, i.e. it does not have enough energy to break chemical bonds. For this reason, it does not cause the same damage as ionizing radiation, such as X-rays and gamma rays.
In 2024 the Philippine FDA published Advisory 2024-0810 warning that “iTeraCare blowers” were being promoted by some resellers as medical devices without being registered as such. The advisory does not say the device is dangerous; it says it must not be sold with medical claims. We agree — that is why on this site you will find iTeraCare described as what it is: a wellness device.
iTeraCare devices manufactured by Prife International carry electrical-safety and quality certifications for household appliances (CE marking for the European market, among others), and the manufacturer publishes its own quality documentation. These certify safety as an appliance — they are not medical approvals, and we will never present them as such.
Terahertz radiation is generated by acceleration of charged particles. This can happen in a number of ways, including:
Bremsstrahlung: This process involves a charged particle changing direction and emitting radiation.
Free electron lasers: Use an electric field to accelerate electrons in a vacuum tube. Electrons emit terahertz radiation as they are accelerated.
Quantum cascade lasers: Employ a semiconductor structure designed so that electrons are accelerated and emit terahertz radiation as they move through it.
There are also other processes for generating terahertz radiation, such as the impact of high-energy electrons on material or the interaction between laser light and material.
Although terahertz radiation is safe for humans and living beings, at high powers it can cause damage to cells and DNA. As research progresses, we will be able to better understand the long-term effects of exposure to such radiation.
If you must expose yourself to terahertz radiation, we recommend that you take certain precautions, such as wearing protective clothing and discussing the risks with your physician, especially if you have an implanted medical device.
Terahertz radiation is an emerging technology and more research is needed in the field to fully understand its long-term effects. However, its use at low potencies, as is the case in iTeraCare therapies, is generally considered safe.
People use iTeraCare in wellness routines: warmth and relaxation, comfort for tired muscles, and structured-water preparation. Many users report feeling better — and we share their testimonials — but personal experiences are not medical evidence. If you have a health condition, talk to your doctor; iTeraCare complements healthy habits, it does not replace healthcare.
Prices vary by country (Asian markets are the most economical). To see the exact price for yours, choose your country on the iTeraCare Classic, Premium or Pro product pages.
Is iTeraCare FDA approved?
No. iTeraCare is classified and sold as a household wellness appliance, not a medical device, so it is not part of the FDA approval system. Sellers claiming otherwise are wrong.
Is iTeraCare banned by the FDA?
No. The Philippine FDA advisory 2024-0810 warns against selling it with medical claims — it does not ban the device or declare it unsafe.
Does iTeraCare cure diseases?
No. No wellness device cures disease. iTeraCare is used for relaxation and general well-being. Always consult a healthcare professional for any medical condition.
Is it safe to use at home?
Used as instructed, yes: terahertz emission is non-ionizing and low-power. Follow the precautions — avoid implants, pregnancy, open wounds — detailed in our how-to-use guide.
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