THERAGEM PROFESSIONAL T1002


Device Classification Name

lamp, infrared, therapeutic heating

510(k) Number K081505
Device Name THERAGEM PROFESSIONAL T1002
Applicant
MEDICA HEALTH, LTD
2842 kelly brooke lane
deerfield beach, 
FL 
33442

Applicant Contact terri cmorey
Correspondent
MEDICA HEALTH, LTD
2842 kelly brooke lane
deerfield beach, 
FL 
33442

Correspodent Contact terri cmorey
Regulation Number 890.5500
Classification Product Code
ILY  
Date Received 05/29/2008
Decision Date 11/19/2008
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