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Amethyst Bio-mat U.S F.D.A. Approved Class II Medical Device, Japan FDA Medical Device, Korea FDA Medical Device, CE, CVC, PSE, KMFDS, EAC, GMP, TUV, ISO 13485, ISO 9001, P.L.I. (F-2016-0219060).
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.

 
 
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*Legal Disclaimer. Information provided is for informational purposes only and is not a substitute for professional medical advice. No health claims for these products have been evaluated by the United States Food and Drug Administration (FDA), nor has the FDA approved these products to diagnose, cure, or prevent disease. Since every individual is unique, you may wish to consult with your health care practitioner about the use of our product in your particular situation. These claims/statements have not been tested and/or proven on the biomat.
The information on this site has been complied by presenting material (taken out of context) from the research study of the records of doctors: Dr. Takada Maku, Dr. Hatashita Toshiuki, Dr. Hirohuchi Mitchio, and Dr. Ota Nobuoi of Toho University Hospital Japan. These research records were developed over a 40 year period of time. Bibliography: Dr. Sang Whang 'Reverse Aging', MD., Ted Rozema 'Chelaton Therapy', and Dr. Fred Soyka with Alan Edmonds 'The Ion Effect'.
 
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