GAME READY CLASSIC SYSTEM, MODEL 550550


Device Classification Name

massager, powered inflatable tube

510(k) Number K072620
Device Name GAME READY CLASSIC SYSTEM, MODEL 550550
Applicant
COOLSYSTEMS, INC.
2201 dwight way
berkeley, 
CA 
94704

Applicant Contact marianne baldwin
Correspondent
COOLSYSTEMS, INC.
2201 dwight way
berkeley, 
CA 
94704

Correspodent Contact marianne baldwin
Regulation Number 890.5650
Classification Product Code
IRP  
Subsequent Product Code
ILO  
Date Received 09/17/2007
Decision Date 10/31/2007
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