Biomat Certifications

Biomat Certification and Safety

No other infrared mat on the market has FDA medical device registered or the certification levels of the Richway Amethyst Biomat. Your health and safety are the top priorities of Richway and Fuji Bio. U.S. FDA Medical Device 510K Number : K072534

List of Certifications

  1. FDA-registered Medical Device # 2954299
  2. Verification by Registrar Corp that the FDA registration is valid.
  3. FDA 510 (k) Medical Device Approval
  4. Authenticity of GEM QUALITY amethyst used in all BioMats
  5. Better Business Bureau: Liability Report: No customer complaints in the last 3 years!
  6. Award from the United Nations.
  7. Royal Swedish Academy of Sciences Award (they award Nobel prizes)

Biomat FDA 510(k) Medical Device Approval

The Biomat is approved by the FDA for the following claims. The 510k indications for use states: “Temporary relief of minor muscle pain, minor joint pain and stiffness, join paint associated with arthritis, muscle spasms, minor sprains, minor strains, minor muscular back pain, relaxation of muscles, and temporary increase of local circulation where applied.”

Biomat Testing and Certifications

ISO 14001 Environmental Management

ISO 9001 Quality Management

Korea Far Infrared Association Certification

KIFA Certificate

Intertek Biomat 7000 EMF and EMC Safety Test Report

Biomat Negative Ion Test

IEC 60601-1 Medical Electrical Equipment

Biomat Anti-Bacterial Test

Biomat Professional & Single CSA Certification

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