FDA 510(k) Application Details - K161443

Device Classification Name	More FDA Info for this Device
510(K) Number	K161443
Device Name	EksoÖ (version 1.1) and Ekso GTÖ (version 1.2)
Applicant	EKSO BIONICS, INC. 1414 HARBOUR WAY SOUTH, SUITE 1201 RICHMOND, VA 94804 US Other 510(k) Applications for this Company
Contact	Thomas Looby Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PHL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/25/2016
Decision Date	07/19/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review