Over the 10 years that we have been providing these Bio-Mats 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.
Our research repeatedly shows that:
- They are usually not FDA Class II Registered Medical Devices as are these Bio-Mats. Note that registraiton with the FDA is by product. Each product to be sold must be registered.
- They do not have the long durability as do these Bio-Mats.
- Have not had their device used in clinical settings with measurable results.
- Some use vinyl surfaces. Vinyl can be toxic.
- Some emit high EMF.
Here is a detailed confirmation from the Home Office about Fake Bio-Mats
There are a few manufacturers that are making look alike products. Although their products may look and possibly function the same as our products, their parts, quality and service may vary greatly for various reasons. US importers who import/distribute products from any of these three manufacturers are doing so illegally. To legally import/distribute medical devices in the US:
- The manufacturer must prove its products conform to US electrical standards using Nationally Recognized Testing Laboratory (NRTL) recognized by the Occupational Safety and Health Administration (OSHA). Here can find a list from the NRTL. When looking at three manufacturer’s certificates, it seems they only have a CE which means they can import/distribute into EU, but not the US. Their 120V products were also most likely approved as a 220V (CE), not 120V.
Richway products have CSA approval, which allows us to import/distribute legally within North America. We also have a CE, which allows us to important/distribute legally within EU.
- Both manufacturers and importers/distributors/relabelers/repackagers of medical devices must register with the US FDA. Here is a list of the establishments which require registration.
If you do a search on the US FDA website, you'll find some manufacturers are registered with the US FDA but incorrectly (for example, one company is registered but uses the product code IKY which states their classification as a mattress, flotation therapy, and non-powered). And most of the importers/distributors of the look alike products are not registered with the US FDA at all. This means that both the manufacturers/distributors may or may not be aware of the US FDA’s regulatory requirements and therefore increases the uncertainty of the level of quality and service they provide. They also make numerous health claims that can't be backed.
These manufacturers and distributors are new to the market and are all purchasing their products from the same OEM manufacturers, which means they are all competing against each other. We have been around for 20 years and have conducted studies and have the backing by many in the professional field, which they lack. They may be stating numerous health claims but in the case where FDA or FTC becomes aware of this, they will be at risk of getting fined and regulatory action against them.
We have been consistently monitoring and reporting these companies on E-commerce sites when they violate our trademark and trade dress. We have also been reporting them to the FDA and FTC notifying them of their violations and the safety risk they pose to consumers.