FDA 510(k) Application Details - K241822

Device Classification Name	More FDA Info for this Device
510(K) Number	K241822
Device Name	ReWalk« 7 Personal Exoskeleton (50-20-0005)
Applicant	ReWalk Robotics Ltd. DBA Lifeward 3 Hatnufa St., P.O Box 161 Yokneam Ilit 2069203 IL Other 510(k) Applications for this Company
Contact	Pariente Miri 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	06/24/2024
Decision Date	03/12/2025
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