U.S F.D.A. Approved Class II Medical Device















Amethyst Bio-mat U.S F.D.A. Approved Class II Medical Device

Device Classification Name pad, heating, powered
510(k) Number

K072534

Device Name BIO-MAT 2000
Applicant

Richway & Fuji Bio Inc. INTL., INC.

1314 South King St., Suite 520

Honolulu,  HI  96814

Contact leroy klima
Regulation Number 890.5740
Classification Product Code
IRT
Date Received 09/07/2007
Decision Date 02/08/2008
Decision substantially equivalent (SE)
Classification Advisory Committee Physical Medicine
Review Advisory Committee Physical Medicine
Statement/Summary/Purged Status Summary only
summary summary
Type

Traditional

Reviewed by Third Party No
Expedited Review No

 

The information presented in the US FDA’s Medical Device 510K indications for use:

– Temporary relief of:


  • Minor muscle pain

  • Minor joint pain and stiffness

  • Joint pain associated with Arthritis

  • Muscle spasms

  • Minor sprains

  • Minor strains

  • Minor muscular back pain

– Relaxation of muscles
– Temporary increase of local circulation where applied.