FDA Registration
Active
🇨🇳 China
Electric wheelchair
Reg #: 3031147096
·
FEI: 3031147096
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- NANJING E-TAKE MEDICAL APPARATUS CO.,LTD
- Registration Number
- 3031147096
- FEI Number
- 3031147096
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3F, Bld14-B, 6 Longzhong Rd, Tangcheng Industrial Park, Liuhe District
- City
- Nanjing Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K242989
Owner / Operator
- Firm Name
- Nanjing E-take Medical Apparatus Co.,ltd
- Operator Number
- 10092528
- Address
- 3F, Bld14-B, 6 Longzhong Rd, Tangcheng Industrial Park, Liuhe District
- City
- Nanjing
- State
- Jiangsu
- Postal Code
- 211500
- Country
- CN
- Correspondent
- Owen Hong
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 | 2025-01-17 |
Proprietary Names
Electric wheelchair
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device