FDA 510(k) Application Details - K250405

Device Classification Name	More FDA Info for this Device
510(K) Number	K250405
Device Name	Nerivio; Nerivio Infinity
Applicant	Theranica Bio-Electronics Ltd 4 Ha-Omanut St Netanya 4250438 IL Other 510(k) Applications for this Company
Contact	Alon Ironi Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QGT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/13/2025
Decision Date	05/14/2025
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