FDA 510(k) Application Details - K191587

Device Classification Name	Stimulator, Neuromuscular, External Functional   More FDA Info for this Device
510(K) Number	K191587
Device Name	Stimulator, Neuromuscular, External Functional
Applicant	Bioness Inc. 25103 Rye Canyon Loop Valencia, CA 91355 US Other 510(k) Applications for this Company
Contact	Mercedes Bayani Other 510(k) Applications for this Contact
Regulation Number	882.5810   More FDA Info for this Regulation Number
Classification Product Code	GZI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/14/2019
Decision Date	09/12/2019
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