We are continuing our discussion from the last post because we have more info on the BioMat and FDA approval. In a succinct summary, we are allowed by the FDA to say the following about the BioMat. With the 510K classification, indications of use include:
- Reduces inflammation
- Eases minor joint pain and stiffness
- Relieves minor muscle pains in areas where applied
- Minor muscular back pain
- Improves sleep (if associated with pain relief)
- Reduces stress and fatigue
- Soothes and relaxes
- Increases blood circulation in areas where applied
- Increases tissue oxygen (where applied)
- Supports the immune system.
As you read through these indicators, you begin to see the benefits and/or positive outcomes that can come from BioMat usage. And the FDA goes one step further to spell out specific 510K benefits:
- Promotes relaxation by application of heat
- Relaxation of muscles
- Promotes restful sleep for those with occasional sleeplessness
- Temporary increase of local circulation where applied
- Temporary relief of muscle spasms
- Temporary relief of minor muscle, and joint pain and joint stiffness
- Temporary relief of sprains and strains
- Temporary relief of joint pain associated with arthritis.
The BioMat is included in these above lists because of its 510K classification. Having these guidelines is helpful to know what and how we, as authorized distributors, can represent the BioMat. We are not making claims about any diseases or classes of diseases. You will note that these are broad, generalizing statements rather than referring to specific symptoms or characteristics of any disease. Also, the BioMat does not “belong” to any specific class of drugs and it is not a substitute for a product that is a therapy for a disease.
As you can see, being integrous is first and foremost for us and Richway to maintain its on-going FDA approval. Interested in learning more about the BioMat’s FDA and FTC compliance? Contact us at 952-829-1919.
