FDA Registration
Active
🇮🇱 Israel
AFISCOOTERS
Reg #: 8043457
·
FEI: 1000646143
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Afikim Electric Vehicles (S.A.E. AFIKIM)
- Registration Number
- 8043457
- FEI Number
- 1000646143
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Kibbutz Afikim
- City
- Kibbutz Afikim Northern
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K051028
Owner / Operator
- Firm Name
- Afikim Electric Vehicles (S.A.E. Afikim)
- Operator Number
- 10025988
- Address
- Kibbutz Afikim
- City
- Kibbutz Afikim
- State
- Northern
- Postal Code
- 15148
- Country
- IL
- Correspondent
- Shuki Azoulay
US Agent
- Business Name
- AFIKIM SCOOTERS USA LLC
- Contact Name
- OFER TSORAN
- Address
- 1011 8TH STREET, SUITE 104
- City
- Daytona Beach
- State
- FL
- ZIP
- 32117
- Country
- US
- [email protected]
- Phone
- 646 6883238
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Vehicle, Motorized 3-Wheeled | INI | Class 2 | Physical Medicine | No | 2008-05-28 |
Proprietary Names
AFISCOOTERS
Establishment Types
Export Device to the United States But Perform No Other Operation on Device