WS FAR INFRARED THERAPY UNIT, MODEL # TY-101 SERIES


Device Classification Name

lamp, infrared, therapeutic heating

510(k) Number K080465
Device Name WS FAR INFRARED THERAPY UNIT, MODEL # TY-101 SERIES
Applicant
WS FAR IR MEDICAL TECHNOLOGY CO., LTD.
2904 n boldt drive
flagstaff, 
AZ 
86001

Applicant Contact jennifer reich
Correspondent
WS FAR IR MEDICAL TECHNOLOGY CO., LTD.
2904 n boldt drive
flagstaff, 
AZ 
86001

Correspodent Contact jennifer reich
Regulation Number 890.5500
Classification Product Code
ILY  
Date Received 02/21/2008
Decision Date 07/18/2008
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