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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).
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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 & Fuji Bio Inc. 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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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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