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
- [email protected]
- Phone
- 508 8018146
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powered Exoskeleton | PHL | Class 2 | Physical Medicine | No | 2019-06-10 |
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