FDA Registration
Active
🇮🇱 Israel
ReWalk(TM) Personal
Reg #: 3007615665
·
FEI: 3007615665
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
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
- K160987
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 | 2016-08-04 |
Proprietary Names
ReWalk(TM) Personal
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device