FDA Registration
Active
🇨🇳 China
WHILL Model C2
Reg #: 3009265647
·
FEI: 3009265647
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Kunshan Hi-Fortune Health Products Co., Ltd.
- Registration Number
- 3009265647
- FEI Number
- 3009265647
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- NO.625 Juxiang Road, Zhangpu Town
- City
- Kunshan City, Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K213383
Owner / Operator
- Firm Name
- Kunshan Hi-Fortune Health Products Co., Ltd.
- Operator Number
- 10036888
- Address
- NO.625 Juxiang Road, Zhangpu Town
- City
- Kunshan City
- State
- Jiangsu
- Postal Code
- 215321
- Country
- CN
- Correspondent
- hongfa zhi
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 | 2021-11-15 |
Proprietary Names
WHILL Model C2
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)