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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. 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. The Biomat 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. These claims/statements have not been tested and/or proven with 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. Hatashita Toshiuki, Dr. Takada Maku, 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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