This week, we are sharing information about additional licensure and certification of the BioMat.

Bio-mats secure licensure from the National Recognized Testing Laboratory (NRTL); knock-offs of the BioMat do not. The knock-offs cannot label their products as infrared devices so they call it “bedding.” This is inaccurate, mis-labeled and misleading.

Knock-offs also do not have 510K licensure or certification. All infrared devices must have the 510K label or they can’t claim/label it as an infrared ray device. (NRTL is a pre-requisite for 510K.) No PEMF mats have the FDA 510K label; that is why they call it bedding.

Knock-offs do not have a Unique Device Identification (UDI) system which traces each medical device distributed. The BioMat does have a UDI and without it, there’s no tracking, credibility or quality assurance.

Knock-offs do not have MSDAP or ISO 13485 which audits the quality of manufacturers and regulates requirements on devices. With the BioMat’s Food and Drug Administration (FDA) Class II medical device status, it must have either MSDAP or ISO 13485. (Again, this speaks to the BioMat highly regulated and controlled manufacturing environment.) Further, MSDAP requires NRTL licensure and a company cannot ship to the United States or Canada without mislabeling issues.

Finally, Good Manufacturing Practices (GMP) are required for medical devices. Flimsy and shoddy workmanship on knock-offs do not comply with GMP. We have confidence and security of knowing Richway International’s manufacturing is top-notch. They are committed to passing all requirements and stipulations with flying colors!

From this information, you can see Richway has applied and secured additional licensure and certification of the BioMat. This is why it makes sense to purchase from the “real” Richway BioMat manufacturer and company?! Next week, we will write more about Richway & Fuji Bio Inc. as the proven industry leader. You won’t want to miss that blog entry. And of course, in the meantime, if you have questions, please connect with us at 952-829-1919.