FDA Registration
Active
🇨🇳 China
Toe Straightener, Toe Splint, Bunion Corrector
Reg #: 3013856565
·
FEI: 3013856565
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- HENGSHUI GANGSHENG MEDICAL INSTRUMENTS CO., LTD
- Registration Number
- 3013856565
- FEI Number
- 3013856565
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1000 meters South of Dadi Town Government, Dadi village, Dadi Town, Shenzhou City
- City
- Hengshui Hebei
- Country
- CN
Owner / Operator
- Firm Name
- Hengshui Gangsheng Medical Instruments Co., Ltd
- Operator Number
- 10056289
- Address
- 1000 meters South of Dadi Town Government, Dadi village, Dadi Town, Shenzhou City
- City
- Hengshui
- State
- Hebei
- Postal Code
- 053800
- Country
- CN
- Correspondent
- XinYing Liu
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 |
|---|---|---|---|---|---|
| Orthosis, Foot Drop | OHI | Class 1 | Physical Medicine | No | 2023-11-09 |
Proprietary Names
Toe Straightener, Toe Splint, Bunion Corrector
Ankle Foot Orthosis (AFO); AFO; Adjustable Foot Drop Brace; Foot Brace Shoe; Dual Foot Stretcher; Foot Stretcher;
Foot Drop Splint, Night splint: Dorsal Night Splint: Foot drop brace; Below Knee Orthosis (BKO);
Foot Pad: Arch Support Cushion/Arch Support Pad; Toe Separator, Toe Cap, Toe Protector, Toe Corrector, Bunion Protector,
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)