|FDA Medical Device #2954299|
|Device Classification Name||pad, heating, powered|
|Device Name||BIO-MAT 2000|
|RICHWAY INTL., INC.|
|1314 south king st., suite 520|
|honolulu, HI 96814|
|Classification Product Code|
|Decision||substantially equivalent (SE)|
|Classification Advisory Committee||Physical Medicine|
|Review Advisory Committee||Physical Medicine|
|Statement/Summary/Purged Status||Summary only|
|Reviewed by Third Party||No|
|BMP Size|| 700 x 1880mm / 27.56″x74″|
|Net Weight||13kg / 28lb Without Controller|
|Performance Temperature||35C-70 / 95F-158F|
|Amethyst Size||5mm – 12mm|
|Amethyst Color||Natural Violet Clear|
|Cut & Shape||Tumbled|
|Polariscope Test|| Dr|
|Fluorescence LW||No Refraction, Natural factor|
It’s Richway professional set with amethyst pillow and Biomat 7000MX professional size.
The Biomat is not a device to cure cancer or any other disease.
The Biomat does not claim any medical benefits and does not claim to cure any disease or medical condition. It does not claim any diagnosis or treatment and only claims the statements in the Medical Device of the FDA’s regulation.
Specific medical advice should be obtained from a licensed health care practitioner.
Any information and personal testimonies about the Biomat does not reflect the Biomat’s claim.