TQ SOLO AND SOLO PRO AND LS50 ACCESSORY AND MR4 MULTI RADIANCE THERAPY SYSTEM


Device Classification Name

lamp, infrared, therapeutic heating

510(k) Number K080102
Device Name TQ SOLO AND SOLO PRO AND LS50 ACCESSORY AND MR4 MULTI RADIANCE THERAPY SYSTEM
Applicant
ESCADA INTERNATIONAL, INC.
13 red fox ln.
littleton, 
CO 
80127

Applicant Contact kevin walls
Correspondent
ESCADA INTERNATIONAL, INC.
13 red fox ln.
littleton, 
CO 
80127

Correspodent Contact kevin walls
Regulation Number 890.5500
Classification Product Code
ILY  
Subsequent Product Code
GEX  
Date Received 01/14/2008
Decision Date 08/20/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No