BIO-MAT 2000


Device Classification Name

pad, heating, powered

510(k) Number K072534
Device Name BIO-MAT 2000
Applicant
RICHWAY INTL., INC.
1314 south king st., suite 520
honolulu, 
HI 
96814

Applicant Contact leroy klima
Correspondent
RICHWAY INTL., INC.
1314 south king st., suite 520
honolulu, 
HI 
96814

Correspodent Contact leroy klima
Regulation Number 890.5740
Classification Product Code
IRT  
Date Received 09/07/2007
Decision Date 02/08/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No