FDA 510(k) Application Details - K081247

Device Classification Name	Equipment, Traction, Powered   More FDA Info for this Device
510(K) Number	K081247
Device Name	Equipment, Traction, Powered
Applicant	ITO CO., LTD. 1201 RICHARDSON DR., SUITE 140 RICHARDSON, TX 75080 US Other 510(k) Applications for this Company
Contact	KENNETH L BLOCK Other 510(k) Applications for this Contact
Regulation Number	890.5900   More FDA Info for this Regulation Number
Classification Product Code	ITH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/01/2008
Decision Date	08/25/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review