FDA Registration Active 🇮🇱 Israel

ReWalk ReStore

Reg #: 3007615665 · FEI: 3007615665 · Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1

Registration Details

Registration Name
Lifeward LTD.
Registration Number
3007615665
FEI Number
3007615665
Status
Active
Expiry Year
2025
Initial Importer
No
Address
3 Hatnufa St. (6th Floor)
City
Upper Yokneam Northern
Country
IL

Regulatory Submissions

510(k) Number
K190337

Owner / Operator

Firm Name
Lifeward LTD.
Operator Number
10033624
Address
Hatnufa 3
City
Yokneaam
State
Northern
Postal Code
2069203
Country
IL
Correspondent
Miri Pariente

US Agent

Business Name
LIFEWARD, INC.
Contact Name
Larry Jasinski
Address
200 Donald Lynch Boulevard ,, USA
City
Marlborough
State
MA
ZIP
01752
Country
US
Phone
508 8018146

Products

Device Name Product Code
Powered Exoskeleton PHL

Proprietary Names

ReWalk ReStore

Establishment Types

Export Device to the United States But Perform No Other Operation on Device Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility