FDA 510(k) Application Details - K081943

Device Classification Name	Stimulator, Electro-Acupuncture   More FDA Info for this Device
510(K) Number	K081943
Device Name	Stimulator, Electro-Acupuncture
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	000.0000   More FDA Info for this Regulation Number
Classification Product Code	BWK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/08/2008
Decision Date	11/24/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review