Comparisons with Copycat Biomats
Over the 20 years that we have been providing these Biomatats and have received questions regarding similar items and knock-offs. Our research finds that info is taken from our site and slightly modified to imply these knock-offs are the same thing.
Copycat Products Lack All Eight Essential
Certifications of a Medical Device
Our Biomats are medical devices, manufactured with GMP certification, ensuring the highest quality standards in the industry. GMP (Good Manufacturing Practice) manufacturing is a set of quality control and assurance standards that are applied to the manufacturing of pharmaceuticals, medical devices, and other healthcare products.
We follow ISO 13485 regulations in our production processes, ensuring that our devices are safe and effective for our customers. ISO 13485 is an international standard that outlines the requirements for a quality management system in the design, development, production, installation, and servicing of medical devices.
We have obtained NRTL certification for our products, which demonstrates our commitment to electrical safety and compliance with regulations. NRTL stands for Nationally Recognized Testing Laboratory. NRTL certification is a third-party certification program provided by laboratories that have been recognized by the Occupational Safety and Health Administration (OSHA) in the United States.
We comply with all mandatory regulations in Canada, including MDSAP certification and Class 2 medical device licenses, to ensure the safety of our products. MDSAP stands for Medical Device Single Audit Program. It is a program that allows medical device manufacturers to undergo a single audit of their quality management system that satisfies the regulatory requirements of participating countries.
We take CAPA (Corrective and Preventive Action) management seriously, ensuring that all issues are promptly identified, corrected, and prevented to ensure the highest quality of our products.
510K premarketing notification
Our Biomat, which has received FDA approval, is classified as a Class 2 medical device and has obtained a 510K premarketing notification, ensuring compliance with all medical device regulations.
Our products feature UDI numbers, ensuring accurate customer management and providing peace of mind to our users. UDI stands for Unique Device Identifier. UDI numbers are unique codes assigned to medical devices.
Health Canada License
Our Biomat has obtained approval from Health Canada, is classified as a Class 2 medical device, and has obtained a Medical Device License, ensuring compliance with all Canadian medical device regulations. Compliance with the License is mandatory, and failure to comply will result in recall.
|BIOMAT 7000MX||IMITATION HEATING PADS|
|Experience||Richway & 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 been producing 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 professionals 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 on overtime.|
|Research||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.|
|Production||The Biomat is produced in our Korea 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 he 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 late.|
|Top Surface||Since contact with skin is inevitable, the Biomat’s top layer is constructed using thick natural cotton fibers and high-quality polyurethane. The outer surface is durable and can withstand were 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.|
|Waterproof cover||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.|
|Controller||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.|
|Functional design||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.|
|Crystals||We use natural, untreated amethyst, and black tourmaline. We do not use ceramic fillers and all our tourmaline is care fully 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.|
|Amethyst & Tourmaline||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.|
|Proprietary||The Biomat contains two patented layers. The Peach and Grape Seed Layer provides additional natural infrared output. The TOCA Layer is made from black tourmaline. The Biomat emits more negative ions than other mats.||Imitation heating pads use generic materials available from fabric suppliers.|
|Licenses||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. Australia and other countries.|
|FDA||We are Us FDA registered and fully compliant. The Biomat has a 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 property. 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.|