FDA 510(k) Application Details - K191547

Device Classification Name	Stimulator, Nerve, Transcutaneous, For Pain Relief   More FDA Info for this Device
510(K) Number	K191547
Device Name	Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant	ReliefBand Technologies LLC 220 Gibraltar Rd Ste 270 Horsham, PA 19044 US Other 510(k) Applications for this Company
Contact	Barbara Whitman 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	06/12/2019
Decision Date	08/30/2019
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