FDA 510(k) Application Details - K221696

Device Classification Name	More FDA Info for this Device
510(K) Number	K221696
Device Name	ReWalk P6.0
Applicant	ReWalk Robotics Ltd. 3 Hatnufa St. POB Box-161 Yokneam 2069203 IL Other 510(k) Applications for this Company
Contact	Miri Pariente 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	06/10/2022
Decision Date	03/02/2023
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