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Amethyst Biomat 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 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.

 
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*Legal Disclaimer. Information provided is for informational purposes only and is not a substitute for professional medical advice. These studies have not been conducted using the Biomat and are only provided for informational purposes. The Biomat is not approved for any use other than what is stated in the User Manual. Richway and Fuji Bio Inc is neither responsible for nor endorses the contents on this page. Users of the Biomat should not expect results similar to the studies.

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