FDA 510(k) Application Details - K191151

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K191151
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	JKH USA, LLC 1142 S. Diamond Bar Blvd, #861 Diamond Bar, CA 91765 US Other 510(k) Applications for this Company
Contact	Bill Quanqin Dai 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	05/01/2019
Decision Date	06/21/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review