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MagnaWave Safety and Studies

MagnaWave Safety and Studies

Many companies that produce low powered PEMF devices often use the argument that more is not always better and that high power devices are dangerous to use. They also indicate that less is always better and the only safe way to utilize PEMF equipment. This information is also presented in a manner to frighten the average consumer. The fact is that in the United States all devices manufactures are subject to the guidance of the FDA. If someone produces a product or device that the FDA finds to be dangerous, it can be removed from the market by the FDA. High powered devices like MagnaWave have been manufactured as Class 1 & 2 off the shelf medical devices for nearly 25 years with no problems or complaints to the FDA that would require regulatory action. Most early PEMF studies were conducted with low power equipment because the high powered equipment was not readily available or feasible with regard to cost for some of the studies. Only in recent years have studies been conducted utilizing high power equipment like the MagnaWave devices. Three such studies are included at the end of this correspondence. The primary difference between the low and high powered devices is the speed of result. The MagnaWave devices with the higher settings provide initially faster results which set up the body to better heal itself. The MagnaWave devices are controllable from very low power to high power which allows for treating at a level that is best suited for the healing process. We at MagnaWave have never maintained that our devices are to be used at the highest power settings all the time. We simply maintain that our devices offer the versatility for the best intensities for providing beneficial energy to the body for the promotion of healing.

MW Rebuttal Equi Med and Seattle Times

What follows is the MagnaWave response to a post that was originally posted on EquiMed in 2011 and then most recently by Deborah Powell on the Whole Horse Connection page. Most of the content of this post was originally written in 2011 and is not current or up to date today. There are many discrepancies in the piece that I will point out. To be fair, I am the owner of MagnaWave and I only wish to clarify some of the statements made.

WHAT YOU SHOULD KNOW BEFORE EXPOSING YOURSELF OR YOUR HORSE TO PEMF DEVICES.

By Deborah Powell

ARTICLE: Electromagnetic products are not new to the horse world. There are a variety of devices such as electro- magnetic blankets, hoof pads, and shin boots that can be found under brand names such as Respond and Centurion. These are PEMF (pulsed electromagnetic field) devices that have lower outputs and have more contained treatments than the high voltage devices discussed in this article. Newer PEMF devices you might recognize are the MagnaWave, the Horse Magnetic Pulser, and the P3, which are all open field electromagnetic devices that use a coil applicator.

RESPONSE: There is a form of Open Field medical research but not open field electromagnetic devices. There is no basis to the term ”Open Field”.

ARTICLE: All of these are advertised as PEMF therapy tools, which are re-makes of the machine called PAP-IMI, which the FDA (Food and Drug Administration) banned from import into the U.S. in January 2008.

RESPONSE: Dr. Pappas (PAP-IMI) and Chuck Wallach began importing and marketing the PAP-IMI device in the early 1990’s. The PAP-IMI is a CE approved medical device (CE0044) for use in Europe. Their problems in the U.S. were due to the fact that they imported the device as a seed germination device (very effective use) and not as a medical device, which is how Mr. Wallach marketed the device, which was considered illegal. A notification was filed with the FDA about this practice. The FDA took no action and ceded the investigation to the State of California. California regulators treated the device as an economic fraud rather than a health hazard. The CDRH did ban the company from enrolling people into studies, which had no basis because of the misrepresentation of the product upon import into the United States. The action by the CDRH effectively stopped the import of PAP-IMI devices into the United States. Dr. Pappas had previously applied to the FDA to market the devices in the U.S. in 1995. The FDA denied (not banned) his request because there was no U.S. based substantiation of the device claims and operation. This is standard procedure because it is necessary for us (MagnaWave) to show safety studies before applying to export a machine abroad as a medical device. The denial of the FDA request is obviously the reason that Pappas and Wallach chose to bring the devices into the U.S. as seed germination systems. If there were substantiation of physical danger the FDA would have taken immediate action as they have many times in the past. No action was or has ever been taken to have a recall of the devices or prohibit the use of the devices. There are several FDA cleared PEMF devices on the market today. MagnaWave actively participates in ongoing safety testing, we have actual studies conducted with our machines and three studies set to begin to be used in conjunction with our pending FDA clearance.

ARTICLE: An electromagnetic field (EMF) is a physical field produced by electrically charged objects that radiates through space. Many common devices in society, such as electric clocks and cell phones, emit EMF levels up to around 400 milligauss (mG). Gauss is the unit of measurement for magnetic fields and one milli- gauss is 1/1000th of a gauss. The EPA (Environmental Protection Agency) in the U.S. and Sweden have made a cutoff point of 1 mG as acceptable exposure levels and recommend people avoid chronic exposure.

RESPONSE: EMF is often considered to be Electro Smog, which is a continuous exposure as mentioned from cell phones, electrical wires and other devices. PEMF is a pulsed nano second energy signal that has a definite start and stop that is a different signal with different Hz. It is not the amount of gauss but the delivery method (constant) that produces electro smog. As previously mentioned MagnaWave’s manufacturer participates in continual safety testing to ensure that we do not produce radio frequency radiation that is considered electrical smog. We also are involved in 3 clinical trials at 3 US universities, as well as published studies. We believe all PEMF companies should have independent safety testing done on their equipment.

ARTICLE: This is why it is significant to note that some manufacturers advertise emitted magnetic energy of up to 19,200 gauss for their electromagnetic open field devices marketed for horses.

RESPONSE: Covered above.

ARTICLE: One simple way to think of this is comparing it to an MRI (Magnetic Resonance Imaging), which uses electromagnetic outputs of 5,000 to 30,000 gauss. When an MRI test is administered you are alone in a sealed chamber protecting the rest of the medical staff from exposure. It is considered serious business when using this much gauss. However, PEMF devices that have an open field type application allows the electromagnetic fields to spread throughout the barn. Currently there is not enough research to conclusively prove the dangers of EMF devices however, the EPA still states there is “reason for concern” and it advises “prudent avoidance.” “Electric and magnetic fields are invisible lines of force that surround any electrical device that is plugged in and turned on. EMFs are made up of waves of electric and magnetic energy moving together (radiating) through space. Electric fields are pro-duced by electric charges and magnetic fields are produced by the flow of current through wires or electrical devices” – U.S. EPA

RESPONSE: One of the most common concerns for people researching PEMF therapy is associated with the negative effects of other EMFs in the environment, and the so- called ‘electro-smog’ they create. There are many differences between these harmful EMFs and the therapeutic PEMFs generated by PEMF devices.

Cumulative exposure – hour after hour, day after day – to EMFs is of the greatest concern. Ordinary household appliances tend to generate larger cumulative EMF exposures than power lines, as most people do not live close enough to power lines to be dramatically affected by their EMFs. The same cannot be said of kitchen appliances, computers, televisions, cell phones, and even electric outlets (especially if it’s directly behind the headboard of a bed). Though EMFs from appliances drop off at a distance of about 16 feet, people are generally much nearer than that to the source of the electromagnetic field – typically 18 inches from computers, a few feet from televisions, and practically no distance from cell phones. The types of harmful EMFs present in these findings have significantly shorter wavelengths and higher frequencies than therapeutic PEMFs. The electromagnetic spectrum is huge, encompassing all possible wavelengths and frequencies, including X-ray, microwaves, radio waves, visible light, infrared, etc. Practically speaking, for therapeutic magnetic field applications, the spectrum is quite narrow. The goal of a PEMF system is to produce a magnetic field that will not only be supportive to the body’s natural functions but to use a wavelength that will completely penetrate the body. This requires a very long wavelength and low frequency. Most PEMF systems produce frequencies in the Extremely Low Frequency to Very Low-Frequency range on the electromagnetic spectrum. These frequencies (below 10,000 Hz) do not induce heating actions. PEMF devices also contain various levels of filtering inside the control unit or frequency generator portion of the system, which clean up the aforementioned surges/spikes that

often come out of the household outlets we use to power the device itself. Dr. Wm. Pawluk.

ARTICLE: During a session with a pulsed electromagnetic field device, the horse’s muscles will visibly spasm under the coil applicator. This occurs because the electrical current within the muscle is reacting to the strong stimulus, causing the muscles to involuntarily contract near the PEMF coil applicator. These intense muscle contractions are an uncontrolled, random, and undesirable side effect according to Ben Philipson, expert, on PEMF therapy and biomedical electronic engineering.

RESPONSE: Ben Philipson is the CEO of Curatronic Ltd that produces a low powered PEMF device that is not strong enough to produce muscle response. Certainly, his response is in support of his PEMF equipment. Our devices can be used to scan the body, at a low power, to find sensitive areas or the power can be adjusted to provide a deep comfortable mechanical massage with muscle movement.

ARTICLE: High-voltage PEMF devices could be perceived as actual therapy devices because they provide a very short analgesic effect, which is similar to giving your horse strong painkillers. Unfortunately, this side effect can lead people to believe the horse is being healed when in reality the underlying problem is not being addressed.

RESPONSE: Pain relief is not a side effect but a good result. If the indication is anatomical then the result is difficult to sustain, but if the indication is soft tissue then the result can often be reversed and no longer problematic, which could be considered as healed.

ARTICLE: There are a variety of devices marketed as pulsed electromagnetic field therapy devices, which include the previously mentioned MagnaWave, Horse Magnetic Pulser, and P3. Horse people are drawn to these devices because they appear easy to use and the manufacturers claim a wide range of benefits and conditions that the devices can supposedly heal. The problem is that these are experimental devices with no FDA approval. While some could claim benefits, in reality the benefits are unknown and the possibly severe risks are also unknown.

RESPONSE: For clarification, FDA approval is not required for a device to be used for veterinary purposes. A quick check of many regularly used veterinary devices will show that many devices and products are not FDA cleared. Devices that are said to be FDA cleared are often human devices that have been approved for other applications than what they are being used for in veterinary services. In veterinary, manufacturers are subject to FDA compliance. Which means that the FDA can bring action, to stop or restrict operation based on documented and substantiated complaints. There have been no substantiated complaints filed with the FDA with regard to the use of PEMF. The results from the use of MagnaWave can be easily evidenced by visiting our social media sites or by visiting our website.

ARTICLE: There are downsides to acquiring FDA approval because it can be expensive and time-consuming, which favors large companies.

RESPONSE: The manufacturer of the MagnaWave devices is in the final stages of being granted FDA clearance, which was covered above.

ARTICLE: However, the FDA should be considered a protection agency that is looking out for the safety of the consumer – you. A product that has not been FDA approved and heavily pollutes the area with EMF is not likely worth using when there are safe, effective options available. The basic technology behind EMF devices easily goes back to the 1940s, therefore when the Medical Device Amendments were enacted in 1976 the technology was in essence “grandfathered in.” Unfortunately, this means that even though the devices are not FDA approved and the original PAP-IMI was banned (False Statement) from import there are still many high-voltage PEMF devices in use. Many of the manufacturers of PEMF open field devices for horses make claims based on studies that are not valid comparisons because these studies were using much lower levels of EMF exposure. Also, the EMF devices for horses use a method of treatment that is extremely uncontained, which causes electro-smog.

RESPONSE: MagnaWave and our manufacturer have always worked to produce devices that were not considered to be electro-smog producing devices. Calculations show that it would take seventeen hours of continual exposure to our spark chamber devices in order to receive one second of the exposure electro-smog released by your cell phone or other electrical devices in your home or barn. Our new digital devices have gone through complete testing to ensure that they are not emitting dangerous EMF electro-smog. Also, MagnaWave has an actual published study demonstration the results achieved with our devices.

ARTICLE: According to the EPA website, low levels of milligauss can disperse up to 3 feet, which makes it hard to imagine how much greater of a distance 19,200 gauss will travel. On the website for the Horse Magnetic Pulser it states, “All cell phones, land line phones, TV remotes, watches, and anything that might be damaged by an intense high voltage surge must be kept at least ten feet from the coil when the Horse Magnetic Pulser is in operation.” If a device is able to cause electronics to shortage, what possible effects is the body experiencing? Also, the intensity of the high voltage surge might not be strong enough to damage electronics after 10 feet, however that does not mean that the effects of the electromagnetic field has dissipated. With that being said, do we really want any horse receiving this type of exposure?

RESPONSE: The disclaimer is made because the magnetic field produced could lead to battery depletion on some devices, so precaution is recommended for all battery- controlled devices. The quote presented reads a little strong and frightening and is taken out of context. If taken as presented the warning made no mention of being dangerous to people but only battery-powered devices, the author injected the danger aspect.

ARTICLE: The people at the most risk from using PEMF devices are the therapists and/ or staff because they have regular exposure to EMF. The EPA states that chronic exposure to EMF should be avoided due to possible health risks. Even though in theory the therapists or staff members are only treating the horse, in reality each time they use an open field device they are receiving equal treatment. (This information is repetitive and was covered earlier in this response.) Also, it is especially dangerous if there are any pregnant women – or horses – in the barn while the device is running because the electromagnetic radiation (fear statement) dispersed could cause miscarriages or birth defects.

RESPONSE: We all know that exposure to most anything is contraindicated with regard to pregnancy in humans or animals. There is also no substantiation to the statement of danger. If that were the case, those pregnant would need to live in a bubble to remain safe from the actual EMF electro-smog that they are subjected to daily.

ARTICLE: here is also extreme risk for people with heart conditions. For a person with a heart murmur or arrhythmia, it can be life threatening to be in proximity to a PEMF device while it is running.

RESPONSE: Absolutely no substantiation to this claim as PEMF has been shown to be beneficial in the treatment of Arrhythmia or heart murmur, google PEMF Arrhythmia.

ARTICLE:

Dangers/Risks of Exposure to EMF (emitted from PEMF devices): 
Cancer, esp. childhood leukemia
Miscarriages,
Nausea,
Headaches,
Chronic fatigue,
Birth defects
Extremely dangerous for people with heart conditions

In summary, it would be wise to choose treatment modalities that will not harm the animals and any living creature surrounding them that you are treating. Just because the horses are so often good sports towards our selfish intentions does not mean that they should be subject to a treatment that they do not appreciate nor respond positively to, and that will increase their risk of cancer, or stimulate the cancer that resides within them already.

RESPONSE: No basis or clinical substantiation to this claim.

PEMF has been found to help the body produce oxygen to fight cancer cells but to also reduce tumor size for easier treatment. MagnaWave PEMF equipment and the equipment of others is in use at cancer treatment centers around the world. (documentation available) A new device for brain tumors has recently been by the FDA for use in the United States.

ARTICLE: Electro- therapy in the form of micro current has been proven over and over again to be safe and effective; magnetic therapy has also been safely used for decades and longer. One or the other is good therapy, but to combine the two is a bit much for a system as delicate as the which resides within the horse.”

RESPONSE: The final sentence says it all, the author of this piece is currently involved with a company that produces a micro current device and obviously penned this article as a defense and promotion of their product. I see MagnaWave PEMF as a very complementary and safe modality to be used in conjunction with micro current and other therapies. I have in fact treated thousands of horses, small animals and humans working with other complementary modalities with fantastic results. My recommendation is to find the modality or modalities that you are most comfortable with that provide the results you are looking for, and go out and help those in need of relief.

Studies: Studies conducted using MagnaWave equipment:

Prostate http://0s4.com/r/781QMG ,

Herniated Disc http://0s4.com/r/781QMG ,

Knee Osteoarthritis http://0s4.com/r/781QMG ,

Knee Overview http://0s4.com/r/9OZKF7 .