FDA 510(k) Application Details - K181645

Device Classification Name	Stimulator, Nerve, Transcutaneous, For Pain Relief   More FDA Info for this Device
510(K) Number	K181645
Device Name	Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant	Pierenkemper GmbH Am Geiersberg 6 Ehringshausen 35630 DE Other 510(k) Applications for this Company
Contact	Thorsten Reichel Other 510(k) Applications for this Contact
Regulation Number	882.5890   More FDA Info for this Regulation Number
Classification Product Code	GZJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/22/2018
Decision Date	08/13/2020
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