FDA 510(k) Application Details - K171366

Device Classification Name	Stimulator, Peripheral Nerve, Implanted (Pain Relief)   More FDA Info for this Device
510(K) Number	K171366
Device Name	Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Applicant	Stimwave Technologies Inc.,DBA StimQ LLC 901 East Las Olas Boulevard , Suite 201 Fort Lauderdale, FL 33301 US Other 510(k) Applications for this Company
Contact	Elizabeth Greene Other 510(k) Applications for this Contact
Regulation Number	882.5870   More FDA Info for this Regulation Number
Classification Product Code	GZF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/09/2017
Decision Date	08/04/2017
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