FDA 510(k) Application Details - DEN200046

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN200046
Device Name	Neurolutions Upper Extremity Rehabilitation System
Applicant	Neurolutions, Inc. 1101 Pacific Avenue, Suite 300 Santa Cruz, CA 95060 US Other 510(k) Applications for this Company
Contact	Kern J. Bhugra Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QOL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/23/2020
Decision Date	04/23/2021
Decision	DENG -
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review