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Copycat Biomat Products
In the last few years, there have been many Biomat® copycats popping up. These copycat products may look just like our products, but none of them have the Biomat®’s advanced technology, certificates, or safety licenses to manufacture or distribute medical products.
Due to many complaints by medical professionals, MedWatch, which is the FDA’s program for reporting serious problems regarding medical products, have taken down many Biomat® copycats for either being illegally imported, or failing to have the correct license and certificates.
Read below for more information on differentiating Biomat® from copycat products.
Copycat products typically do not have an NRTL License
Per FDA regulations, any “Powered Heating pad” must have an NRTL (National Recognized Testing Laboratory) 120V Electric Safety License. Without an NRTL License, heating pads should not be able to import to the USA or Canada.
How copycat products get imported without an NRTL License:
A 510(k) is a premarket submission to demonstrate to the FDA that the device has demonstrated to be marketed as safe and effective. All infrared ray heating devices must have a 510(k). Without a 510(k), they cannot claim their products as an “Infrared Ray” device. NRTL License is a prerequisite for a 510(k).
Copycat products typically do not have a UDI management system.
A UDI System, or Unique Identification System, is how medical devices each get assigned a unique identifier. The Biomat® is considered a Class II Medical Device, which will need to be managed under a UDI System. Through a UDI system, each individual device can be tracked and traced as a part of the requirements for distributing medical devices.
Copycat products typically do not have an MDSAP or ISO 13485
MSDAP, or Medical Device Single Audit Program, is a program that helps conduct regulatory audits on the quality of the manufacturers of these medical devices, which is a requirement for multiple regulations.
ISO 13485 are a specific set of requirements for regulatory purposes for medical devices. Class II Medical Devices must be managed under an MDSAP or ISO 13485 system.
Since MDSAP requires an NRTL license, these copycat products are typically missing these as well. Without MDSAP, copycat products cannot get a Medical Device License in Canada.
Copycats typically don’t have GMP License
GMP (Good Manufacturing Practices) Licenses are guidelines required by certain agencies that control the authorization and licensing of the manufacturing of many different goods, which also includes medical devices. Without a GMP License, companies cannot produce Medical Devices.
Why do many of these copycat companies not have the required licenses and certificates?
Getting these licenses and certificates are expensive, time-consuming, and difficult. Once you obtain these licenses, you place yourself under more scrutiny, and manufacturing will now need to be constantly inspected every quarter.
Due to these reasons, copycat companies tend to be missing these licenses and certificates.
The Bureau of Consumer Protection has investigated “Infrared Ray Heating Devices” and found many of them do not meet the requirements to be imported or marketed in the US.
Consumer Protection associations have reported to US Customs to block the importing of these copycat products, as well as removing any medical device that does not meet the standards from online shopping sites such as Amazon.
Biomat 7000mx VS. Imitation Heating Pads
Richway and Fuji Bio created the Biomat over 20 years ago. Through research, development and feedback from health professionals, we designed a wellness tool used by tens of thousands worldwide. The Biomat continues to be the leader in far infrared and negative ion therapy.
Some textile factories have beenproducing heating pads designed to look like the Biomat. They even use fake pictures of their staff with fake names. Importers buy these pads in bulk and stick their own “brand names” on them. Some importers mislead customers into believing their heating pads are made in the USA. In reality, their products are imported from China.
USED BY PROFESSIONALS
Thousands of health and wellness professional are using the Biomat in their practices. The Biomat is used by medical doctors, physical therapists, integrative medical doctors, holistic practitioners, yoga teachers, massage therapists, acupuncturists, and naturopaths around the world.
No health and wellness professionals use imitation pads in their practice. Customers have informed us that the build of these pads are not consistent, and they do not hold up over time.
Independent studies have been done using the Biomat over the years. The Biomat has also been featured in books, and other publications.
Manufacturers of imitation pads reference studies found online, however none of these studies were done using their actual product. There is no proof that their heating pads have the same effectiveness as the Biomat.
The Biomat is produced in our Korean medical supply facility under strict quality control and environmental standards. We do it all from research and development, design and to manufacturing. Every step of the way our products are inspected and exceed safety standards.
The importers of cheap heating pads are not involved in the research and development or the design of the final product. Textile factories copy our Biomat and persuade the customer into thinking they are getting something similar, however they do not last.
Since contact with skin is inevitable, the Biomats top layer is constructed using thick natural cotton fibers and high-quality polyurethane. The outer surface is durable and can withstand wear and tear. No glues are used on our amethyst. The breathable fibers allow infrared heat to easily penetrate the body.
Imitation pads are made using various materials. Many tops contain synthetic fabrics, some wrinkle because of its low tolerance to heat. Others contain mesh, which can snag and rip overtime. Another style of pad uses stone discs glued onto the surface. Users have told us the discs can fall off since the glue is affected by heat and leach fumes.
Our waterproof cover is made of 100% polyurethane with proprietary coating to repel liquids while allowing far infrared and negative ions to pass through and reach the user. Its composition is hygienic and can be disinfected.
Some companies tout their “cotton waterproof pads.” However, these pads cannot be sanitized due to the cotton and can stain because of it.
The Biomat comes with a sleek and modern controller. It is simple and easy to understand. Temperatures are shown in Fahrenheit and Celsius. The controller features an auto step down timer for safety and a shutdown timer for convenience.
Heating pad companies use confusing dated looking controllers. Many of them feature temperatures that are only available in Celsius and not Fahrenheit. Many do not have clearly labelled buttons and settings leaving the user confused as to what temperature the pad is set at. Most do not have a step-down temperature function for safety.
The Biomat has a dense thermal protection layer to maximize far infrared and negative ions that reach the user and protect the surface it is on. The serviceable life of a Biomat is 5 years. However, there are thousands of users who are using models over 12 years old.
Many knockoffs are flimsy. Some are even designed in a hazardous two-sided fashion (different stones on both sides of pad). This causes wasted heat and negative ions to travel downward onto the surface the pad is on and away from the user. This can also be a safety issue as the pad may damage the surface it is on.
We only use natural amethyst and black tourmaline in the Biomat. After 20 years of research, development, and studies, we have concluded these are the best gemstones for the best results. Early versions of the Biomat used to contain other gemstones and materials. Over time, the Biomat has evolved through research and now contains the finest materials for optimal results.
Imitators use a wide variety of inferior stones to cut down on cost. They like to tout the efficacy of having a variety of stones, but the truth is materials such as ceramic tourmaline is cheaper than natural black tourmaline and other stones are less effective and cheaper than amethyst.
AMETHYST AND TOURMALINE
We use natural, untreated amethyst and black tourmaline. We do not use ceramic fillers and all our tourmaline is carefully inspected before being used.
Imitation heating pads may contain synthetically produced or chemically treated stones. This treatment will enhance the color but not the effectiveness. To cut costs textile factories are using inexpensive “bio-ceramic tourmaline” balls with reduced negative ion output. Some importers of pads “certify” their stones hoping users will think this will improve the efficacy of their mats.
The Biomat contains two patented layers. The Peach and Grape Seed Layer provides additional natural infrared output. The TOCA Layer is a black tourmaline fabric layer which emits an abundance of negative ions. The Biomat emits almost 2X as many negative ions than other mats.
Imitation heating pads use generic materials available from fabric suppliers.
Biomat is electrically certified in all of the countries we sell to. The Biomat can be shipped to Canada and is licensed as a medical device.
Many companies tout their abundance of certificates. Many are worthless certificates that can be purchased by the imitator for show if the licenses are true it is for the textile factory and not the importer. Most are not licensed medical devices allowed to be sold in Canada, Australla and other countries.
We are US FDA registered and fully complaint. The Biomat has 510(k). Richway & Fuji Bio employs consultants and has full time staff to make sure we comply with FDA law. All of our products are registered with the proper authorities in the countries in which we operate.
Buyer beware. Check if the importer is registered with the FDA. All importers of medical devices are required to be registered on the FDA’s searchable database.
The fly-by-night companies are not registered with the FDA properly. As importers, they are required to be. How they get away with selling their products remains a mystery.
These companies buy from overseas textile factories that do not specialize in medical devices. The manufacturer may be registered but they may not compliant and the importer is usually not registered.
*These statements have not been evaluated by the Food and Drug Administration, Specific medical advice should be obtained from a licensed health care practitioner.