The Healy is a medical device that can be clipped to the users clothing. It supposedly interacts with the body through electrodes that are worn on the wrist, clipped to the ear, or temporarily attached to the skin with adhesive. Its operation is controlled via Bluetooth by a software application that is installed on a smartphone. In 2020, Healy World announced that it would begin multilevel marketing of Healy devices in the United States [1].

Background History

Bioresonance therapy is based on notions that (a) every cell in the body has its own electromagnetic frequency and that (b) diseases can be cured by correcting abnormal frequencies by various means. The idea that diseases could be cured by radio frequency energy was originally exploited by Albert Abrams, M.D., (1864-1924) whom the American Medical Association labeled the “dean of gadget quacks.” In the 1920s and 1930s [2]. Royal Rife claimed that his devices to have developed a device that could destroy microorganisms by vibrating at their “resonant frequency.” Rife derivatives are still marketed.

Proponents attribute the development of bioresonance therapy to Franz Morell, a German physician who spent years investigating the use of electroacupuncture devices and helped Hans Brügemann develop one called the BICOM [3]. A brochure from BICOM’s manufacturer states that Brügemann coined the term “bioresonance therapy” in 1987 to describe the BICOM’s action [3]. Professor Edzard Ernst believes that Brügemann and subsequent bioresonance promoters have used “pseudo-scientific language . . . . as an attempt to present nonsense as science.” [4]. A recent study of two current BICOM equivalents found that they (a) failed to diagnose serious diseases in two seriously ill patients, (b) produced a clean bill of health for a corpse, (c) diagnosed a host of nonexistent health risks nine healthy volunteers, (d) generated no real differences between a wet towel and the volunteers, and (e) had wildly variable results with repeated tests of the wet towel and liver pate [5].

The Healy is said to be a portable descendant of the BICOM device. The Healy GmbH Web site attributes its development to Marcus Schmieke and Nuno Nina:

Marcus Schmieke, born 1966, is the inventor and developer of the Healy™ and TimeWaver® products. For many years Marcus had been thinking about how to let everyone benefit from the possibilities of the TimeWaver technology in a compact and simple way. What he had in mind was a device that everyone could use every day, something compact, simple and practical. A little companion that watches over our health and can help in an innovative way to prevent problems and support healing.

Nuno Nina is a Portuguese researcher and holistic healer. Nuno runs seven private clinics, most of them in Portugal. His field of work is mainly frequency applications and cell biology. Nuno’s experience with thousands of clients has enabled him to compile the theories and findings from his research in the form of a collection of 144,000 so-called “Gold Frequencies.” When he first came into contact with the TimeWaver technology years ago, he immediately suggested combining it with the possibilities of frequency therapy to create something greater than the sum of its parts [6].

A timeline on the TimeWaver website suggests that the TimeWaver development started in 2007 and the first Healy was developed in 2015.

Fanciful Claims

In 2020, a Facebook page associated with Healy stated:

The human body is made up of 100 trillion cells, each requiring healthy cell voltage to stay alive. Quantum physics teaches us there’s no difference between energy and matter. Therefore, we are nothing but energy. Quantum physics teaches us everything within us is the result of motion-creating resonance. The resonance is important to understanding how subtle energy directs and maintains health and wellness in human beings.

Imagine a portable wearable technology designed for total heath, inside and out to assist with energetic imbalances by directing cell communication and increasing cellular energy (ATP) by 500%. By doing so, we can bring the body back to homeostasis (balance). Our cells constantly communicate through resonant frequency much like tuning to the precise channel on your radio or TV. The difference in tuning the station to 102.3 or 102.4 is the difference in a clear signal vs static (signal disruptor). The magic is in the resonance.

Like anything, your cells act as transmitters and receivers. How your cells transmit and receive communication is imperative and can directly impact your health through their signal calling. In the same way, you can disrupt a good signal through poor unhealthy lifestyle, environmental factors etc. you can intentionally disrupt a bad signal (symptomatic poor health). Focusing on healthy frequency communication between cell function can impact your health, vitality, and your brain in ways you can’t possibly imagine [7].

Another affiliated site has added:

Through the science of quantum physics, the Healy can measure your individual frequency via a quantum sensor – then deliver back to you customized and specific frequencies to realign your cellular, emotional and/or energy centers back into bioenergetic balance. To put it more simply, Healy can talk directly to your cellular energy. It can ask your cells what they need to heal and then deliver the exact frequencies your cells asks for—or “resonates with”—to heal [8].

A Healy video commercial has said:

Stay connected to the Cloud via your smartphone. Healy has access to thousands of therapists and clinicians who can supply you with the optimal frequencies. Now possible for everyone. We believe that all this is just the beginning of a new era—an era in which the bioenergetic regeneration of cells will be just as important to humans as a healthy diet and sufficient exercise today [9].

In 2020, a “Healy Programms” brochure promised more than a hundred benefits, including:

  • Activation of the body’s bioenergetic defense system.
  • Bioenergetic calming of the mucous membranes
  • Bioenergetic balancing to help relieve allergic reactions
  • Bioenergetic balancing of visual ability, the hormonal system, the nervous system
  • Bioenergetic stimulation of the body’s energy supply, cell metabolism, mental clarity, the reproductive organs, the body’s excretory processes, the follicles, and the nail bed
  • Bioenergetic regulation of thyroid function and  hormonal balance
  • Bioenergetic promotion of liver metabolism, toxin transport, the lymphatic system, and the beta state
  • Energetically balancing the immune system in cases of infections
  • Bioenergetic optimization of lung function,
  • Bioenergetic reduction of tensions
  • Balancing energetic interference fields in scars
  • Supports inner balance . . . to aid recovery from nicotine addiction.
  • Regulation of bladder energy control
  • Stimulation of the energy field of the spleen and pancreas [10],

Healy also markets a Digital Nutrition App  that, together with a a basic Healy device, will “harmonize your bioenergetic field.” One marketer describes the App this way:

Using the Digital Nutrition Application (“DNA” for short), you don’t have to purchase these substances as supplements. It selects individual Healy DNA frequency programs for you.It creates lists of foods that naturally contain the required substances. The DNA programs contain the resonance frequencies for the individual substances They are designed to support you bioenergetically in better absorbing these substances from your food [11].

Many of Healy’s marketing materials carry a disclaimer to the effect that “Healy and its applications are not acknowledged by orthodox medicine due to a lack of scientific proof in accordance with scientific standards.” It should be noted, however, that claims for the Healy are not merely unproven. There is no logical reason to believe that the  “frequencies” proponents describe are actual physical forces. But that doesn’t stop them from suggesting that they provide great health benefits.

Regulatory Status

Devices with 510(k) clearance from the FDA can be legally marketed in the United States for the purposes for which they are cleared. To obtain such clearance, the manufacturer must show that the devices are substantially similar to a device that the FDA has previously cleared or approved [12]. It is not necessary to prove that the device works. In 2019, the Healy received FDA 510(k) clearance as a Class 2 medical device:

for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arms and legs due to strain from exercise or normal household work activities and for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis [13].

The 510(k) application described it as substantially similar to Omron’s Avail, which is a respectable transcutaneous electrical nerve stimulation (TENS) device that is cleared for the symptomatic relief of various types of pain. TENS devices are postulated to relieve pain by releasing endorphins and/or blocking the transmission of pain through local nerves [14]. If the Healy can deliver electric currents that enable it to function like a TENS device, it would be legally marketable for that purpose. However, it is not cleared for any of the uses related to “bioresonance” that dominate the company’s marketing materials. Any claims that the Healy can be used to prevent, mitigate, cure or treat a disease would be illegal.

Healy might argue that its claims about frequencies and “energetic balance”  should not be regarded as medical claims. In fact, the Healy World Web site states that “Healy also has non-medical applications that use individualized frequencies to help balance your mind and body and relieve stress in support of wellness but not for the treatment of disease.” However, intended use is determined by the context in which a claim is made. The courts have concluded that the use of “artful language” does not change the significance of illegal acts that amount to the same thing [15,16]. If asked, I believe the courts would conclude that Healy’s claims that mention organs or diseases are medical claims that are illegal without FDA approval. Moreover, the Federal Trade Commission Act requires advertising to be truthful and not misleading—and the FTC, if it acts, generally requires that health-related claims be supported by adequate scientific evidence (typically at least two controlled clinical trials), which Healy admits it does not have.

Several sites have claimed that the Healy is FDA-approved. That is not correct. Approval requires evidence of safety and effectiveness demonstrated by clinical trials. The people claiming approval may not understand the difference between approval and clearance. Or maybe they were misled by the “Certificate of Approval” issued by Harrington Consulting, the company that submitted Healy’s 510(k)  application. The certificate accurately describes the clearance, but the word “approval” might mislead some people. In Australia, the Healy is registered as an “analgesic TENS system,” which it is not.

In March 2021, the FDA ordered 25 companies to stop issuing certificates which state that a company has registered with the FDA. The agency is concerned because the certificates falsely imply that the device has been evaluated, cleared, or approved as effective for its intended purposes. The FDA does not issue any type of device registration certificate, and registration with FDA does not denote approval or clearance of the establishment or its devices [17]. Although the FDA action concerned registration certificates, I believe the same principles would apply to “clearance certificates.”

BICOM’s Regulatory Status

The BICOM device, from which the Healy is said to have descended, is not in the FDA’s 510(k) database. In 2015, the the British Advertising Standards Association  (ASA) ordered Bicom UK, based in Leeds, West Yorkshire, to stop claiming that its “bio-resonance” machines are effective against allergy; food intolerance; bacterial and fungal infections; viruses; toxins; cancer; depression; smoking; weight gain; sports injuries; digestive and skin problems; neurological disorders; irritable bowel syndrome; Crohn’s disease; neurodermatitis; ADHD; dental problems; and even Ebola [18]. In 2019, the ASA ordered Wayne Hardwick (doing business as Body Resonance) to stop claiming claim or implying that Bioresonance could treat conditions unless there was adequate evidence to demonstrate that it could do so [19]. Shortly afterwards, the ASA stated in an advisory that it had “yet to see any evidence that the devices used in bio-resonance therapy can be used to diagnose existing or future medical conditions nor prevent or treat disease or illness.” [20]

In Australia, the BICOM was registered as a biofeedback device. From 2014 through 2018, the Australian organization Friends of Science in Medicine repeatedly complained to the Therapeutic Goods Administration (TGA) that  BICOM and CyberScan (another alleged biofeedback device) were marketed improperly and were not biofeedback devices [21]. (Biofeedback devices issue signals in response to real physiological phenomena such as heart rate, blood pressure, or muscle tone, with a goal of influencing them to improve health outcome.) The complaints included screenshots from more than 200 proponent websites. In 2019, the TGA announced that it would crack down on improper claims made for bioresonance devices [22]. It also engaged an Australian scientific organization to review evidence provided by marketers to support the intended indications for their devices. Following this review, BICOM’s marketers canceled its registration and the TGA canceled the registration of two other devices (Cyberscan and  e-Lybra) [23]. In 2020, an Australian skeptic complained to the TGA about Healy devices [24]. In March 2022, the TGA announced that it had issued issued two infringement notices totaling AU$26,640 to Sydney-based Healy World Australia Pty. Ltd. for advertising an “analgesic TENS system” in alleged breach of the Therapeutic Goods Act 1989. The announcement stated that (a) company had allegedly advertised the device for a purpose other than registered purpose and (b) its advertising contained prohibited representations that referred to depression, anxiety and associated sleep disturbances [25].

The Bottom Line

Healy devices have been claimed to help a wide spectrum of health problems. Their use is based on notions that may sound scientific but lack real scientific support. The FDA has cleared Healy devices for sale in the United States for temporary relief of pain, but claims made for them go far beyond what the clearance allows. Healy’s marketers have even admitted that there is no scientific proof that they work as advertised.

References
  1. Welcome to Healy World. Healy World website, accessed May 12, 2020.
  2. Kaplan J. Doctor Abrams—Dean of machine quacks. Today’s Health, April 1966.
  3. Brugemann H. The fascinating development of bioresonance therapy: Discoveries, research, ideas and hard work. Paper presented at the 45th International Congress for Bicom Users, Fulda, Germany, April 29 to 1 May 1, 2005.
  4. Ernst E. Bioresonance: A study of pseudo-scientific language. Forsch Komplementärmed Klass Naturheilkd 11:171–173, 2004.
  5. Ernst E. Bioresonance: A new and hilariously ingenious study. Edzard Ernst blog, April 9, 2020.
  6. BICOM 2000: The Number 1 in Bioresonance. Published by REGUMED Regulative Medizintechnik GmbH, Gräfelfing, Germany, Aug 3, 2005.
  7. This is why we developed Healy. Healy GmbH website, accessed May 1, 2020.
  8. This is frequency therapy! Float Space website, accessed May 12, 2020.
  9. Healy healing frequencies – Healy frequency overview. Posted to YouTube, April 2, 2020.
  10. Healy programms, June 17, 2019.
  11. Digital Nutrition app. Radiant Resonant Frequencies website, accessed January 31, 2022.
  12. Yellin AK. What are 510(k) clearance and premarket approval? Device Watch, Jan 9, 2009.
  13. 510(k) Summary: K191075, May 26, 2019.
  14. Electrical stimulation for pain. Aetna Clinical Policy Bulletin 0011, March 10, 2020.
  15. Notices of judgment under the Federal Food, Drug, and Cosmetic Act. D.D.N.J., F.D.C. 3381-3383, issued Aug 1951.
  16. Memorandum. USA v Daniel L. Allgyer, U.S. District Court for the Eastern District of Pennsylvania, Case No. 11-02651, Feb 2, 2012.
  17. Barrett S. FDA orders 25 companies to stop Issuing misleading “FDA Registration Certificates.” Device Watch, July 4, 2021.
  18. Advertising Standards Authority adjudication on Bicom UK LLP. Jan 28, 2015.
  19. Advertising Standards Suthority Adjudication on Wayne Hardwick t/a Body Resonance. March 13, 2019.
  20. Bioresonance therapy. ASA online advice, April 16m 2019,
  21. Dwyer J. Letter to John Skerritt, Sept 11, 2018.
  22. TGA cracking down on non-compliant advertising of bioresonance and similar devices. Therapeutic Goods Administration, Aug 16, 2019.
  23. Marron L. Australia cancels all bioresonance devices. Edzard Ernst blog, May 24, 2020.
  24. Vickers M. Complaint to TGA: Healy (device) — Float Space Pty Ltd., June 17, 2020.
  25. Healy World Australia Pty Ltd fined $26,640 for alleged unlawful advertising of a TENS device. Therapeutic Goods Administration news release, March 3, 2022.

Leave a Comment

Your email address will not be published. Required fields are marked *