FDA Registration
Active
🇮🇱 Israel
Ballancer 505 system model 1201-AC
Reg #: 9611425
·
FEI: 3002807566
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MEGO AFEK
- Registration Number
- 9611425
- FEI Number
- 3002807566
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- KIBBUTZ AFEK, POST AFEK
- City
- -- Northern
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K150269
Owner / Operator
- Firm Name
- MEGO AFEK Ac Ltd.
- Operator Number
- 8030066
- Address
- Kibbutz Afek, Post Afek
- City
- Afek
- State
- IL-NOTA
- Postal Code
- 3004200
- Country
- IL
- Correspondent
- Reuven R Yunger
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Massager, Powered Inflatable Tube | IRP | Class 2 | Physical Medicine | No | 2016-02-24 |
Proprietary Names
Ballancer 505 system model 1201-AC
Establishment Types
Manufacture Medical Device