FDA 510(k) Application Details - K131956

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K131956
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	HEALTHCARE INNOVATIONS, LLC 28241 CROWN VALLEY PKWY, STE 510(K) LAGUNA NIGUEL, CA 92677 US Other 510(k) Applications for this Company
Contact	SHEPARD G BENTLEY, RAC Other 510(k) Applications for this Contact
Regulation Number	882.5890   More FDA Info for this Regulation Number
Classification Product Code	NUH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/27/2013
Decision Date	04/24/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review