FDA Registration
Active
🇰🇷 South Korea
Complex Upper & Lower Limbs Gait Training/Rehab. Robot System; HUCA; GTR-A; GTR-P; GTR-PL
Reg #: 3020247338
·
FEI: 3020247338
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HUCASYSTEM INC.
- Registration Number
- 3020247338
- FEI Number
- 3020247338
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Room 507, 3, Jiphyeonjungang 7-ro
- City
- Sejong-si
- Country
- KR
Owner / Operator
- Firm Name
- HUCASYSTEM Inc.
- Operator Number
- 10082477
- Address
- Room 507, 3, Jiphyeonjungang 7-ro
- City
- Sejong-si
- State
- KR-50
- Postal Code
- 30141
- Country
- KR
- Correspondent
- Hyeongsic Kim
US Agent
- Business Name
- Withus Group Inc
- Contact Name
- April Lee
- Address
- 106 Superior
- City
- Irvine
- State
- CA
- ZIP
- 92620
- Country
- US
- [email protected]
- Phone
- 909 2749971
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Isokinetic Testing And Evaluation | IKK | Class 2 | Physical Medicine | No | 2021-08-02 |
Proprietary Names
Complex Upper & Lower Limbs Gait Training/Rehab. Robot System; HUCA; GTR-A; GTR-P; GTR-PL
HUCA-Go
Establishment Types
Manufacture Medical Device