FDA 510(k) Application Details - K160987

Device Classification Name	More FDA Info for this Device
510(K) Number	K160987
Device Name	ReWalk(TM)
Applicant	REWALK ROBOTICS INC. 33 LOCKE DRIVE MARLBOROUGH, MA 01752 US Other 510(k) Applications for this Company
Contact	JOHN HAMILTON 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	04/08/2016
Decision Date	07/22/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review