FDA 510(k) Application Details - K132563

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K132563
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	PINOOK USA 5703 OBERLIN DRIVE STE 306 SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	TEJAS SHAH 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	08/15/2013
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