FDA 510(k) Application Details - K162630

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K162630
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	Mid-America Medical Innovations LLC 2704 Industrial Drive Jefferson City, MO 65109 US Other 510(k) Applications for this Company
Contact	Norm Schroeder 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	09/21/2016
Decision Date	12/20/2016
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