FDA 510(k) Application Details - K142686

Device Classification Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter   More FDA Info for this Device
510(K) Number	K142686
Device Name	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant	AEMED, INC. 4 Turtle Grove Lane Village of Gulf, FL 33436 US Other 510(k) Applications for this Company
Contact	John K Burke 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	09/22/2014
Decision Date	12/18/2014
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