FDA Registration
Active
🇨🇳 China
Electric Wheelchair
Reg #: 3032171348
·
FEI: 3032171348
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- IF HEALTH (XIAMEN) INTELLIGENT TECHNOLOGY CO.,LTD
- Registration Number
- 3032171348
- FEI Number
- 3032171348
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Zone A, 4th Floor, No.3 Building, No.66, xiangyue Rd, Torch High-tech Zone (Xiang'an) Industrial Zone,
- City
- Xiamen Fujian
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K241154
Owner / Operator
- Firm Name
- IF Health (Xiamen) Intelligent Technology Co.,Ltd
- Operator Number
- 10091119
- Address
- Zone A, 4th Floor, No.3 Building, No.66, xiangyue Rd, Torch High-tech Zone (Xiang'an) Industrial Zone,
- City
- Xiamen
- State
- Fujian
- Postal Code
- 361115
- Country
- CN
- Correspondent
- Xiang Gao
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wheelchair, Powered | ITI | Class 2 | Physical Medicine | No | 2024-07-07 |
Proprietary Names
Electric Wheelchair
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device