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.
*Legal Disclaimer. Specific medical advice should be obtained from a licensed health care practitioner.
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