FDA 510(k) Application Details - DEN200050

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN200050
Device Name	Portable Neuromodulation Stimulator (PoNS)
Applicant	Helius Medical, Inc. 642 Newtown Yardley Road, Suite 100 Newtown, PA 18940 US Other 510(k) Applications for this Company
Contact	Lawrence Picciano Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QCF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/04/2020
Decision Date	03/26/2021
Decision	DENG -
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review