FDA 510(k) Application Details - K190337

Device Classification Name	More FDA Info for this Device
510(K) Number	K190337
Device Name	ReWalk Restore
Applicant	ReWalk Robotics Ltd. 3 Hetnufa st., POB Box- 161 Yokneam 2069203 IL Other 510(k) Applications for this Company
Contact	Ofir Koren 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	02/14/2019
Decision Date	06/03/2019
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