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Amethyst Bio-mat FDA Medical Device #2954299
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Device Classification Name
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pad, heating, powered
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510(k) Number
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K072534
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Device Name
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BIO-MAT 2000
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Applicant
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RICHWAY INTL., INC.
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1314 South King St., Suite 520
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Honolulu, HI 96814
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Contact
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leroy klima
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Regulation Number
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890.5740
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Classification Product Code
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Date Received
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09/07/2007
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Decision Date
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02/08/2008
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Decision
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substantially equivalent (SE)
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Classification Advisory Committee
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Physical Medicine
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Review Advisory Committee
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Physical Medicine
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Statement/Summary/Purged Status
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Summary only
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summary
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summary
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Type
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Traditional
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Reviewed by Third Party
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No
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Expedited Review
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No
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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. 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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Amethyst in photo courtesy:
-ology
130 K St.
Old Sacramento, CA 95814
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