TM-400


Device Classification Name

equipment, traction, powered

510(k) Number K081247
Device Name TM-400
Applicant
ITO CO., LTD.
1201 richardson dr., suite 140
richardson, 
TX 
75080

Applicant Contact kenneth l block
Correspondent
ITO CO., LTD.
1201 richardson dr., suite 140
richardson, 
TX 
75080

Correspodent Contact kenneth l block
Regulation Number 890.5900
Classification Product Code
ITH  
Date Received 05/01/2008
Decision Date 08/25/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No