As we are wrapping up our BioMat vs. imitation discussion, it is important to look at the differences in licensure between the two … there is no comparison!
First of all, the original bio-mat is licensed as an FDA Class II medical device; Richway International is registered, approved and fully compliant with the FDA. Richway International’s staff continues to adhere to compliance standards and makes sure all of its distributors comply as well. And Richway registers all of its products with proper authorities in each of the countries we are allowed to sell in. Further, BioMats are fully electrically certified in all countries where distribution is approved, including the United States, Canada and Australia.
For BioMat knock-offs, the importer is likely not FDA registered. (As all medical device vendors are required to be FDA registered, you can easily check this by going to FDA’s database and doing a name search.) While many of the BioMat imitators say they have certain certifications, if you research you will likely find that many of them have actually purchased worthless, on-line certificates. Pay attention if the certificate is from the textile factory and not the importer. Many of these knock-offs are not licensed as medical devices and/or are not even allowed to be sold in Australia, Canada and other countries. Further, importers are required to be fully registered with the FDA; as you dig deeper into sourcing of these knock-offs, you will discover many of them buy from textile factories that do not focus or specialize in medical devices. While the actual manufacturer may be FDA registered, they are likely not compliant; the importer is usually not registered.
Finally, the following language is approved by the FDA – the BioMat is approved to treat 1) minor muscle pain, 2) minor joint pain and stiffness, 3) joint pain associated with arthritis, 4) muscle spasms, minor sprains, strains and muscular back pain, 5) relaxation of muscles, and 6) temporary increase of local circulation where applied. Imitators may make additional claims that are not allowed by the FDA.
We hope you have found this series of blog posts about original BioMats to be helpful. If you have further questions, please connect with us at 952-829-1919.