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:

- Relaxation of muscles
- Temporary increase of local circulation where applied.

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

Authorized Richway Fuji Bio Inc. Retailer since 2005

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