FDA Registration
Active
🇰🇷 South Korea
Soft Knee Brace ACL
Reg #: 3009119999
·
FEI: 3009119999
·
Expires 2025
Products
1
Proprietary Names
9
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ORTEC Co., LTD.
- Registration Number
- 3009119999
- FEI Number
- 3009119999
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 68 DEOKSANG-RO, SASANG-GU
- City
- Busan
- Country
- KR
Owner / Operator
- Firm Name
- ORTEC Co., LTD.
- Operator Number
- 10036960
- Address
- 68 DEOKSANG-RO, SASANG-GU
- City
- Busan
- State
- KR-NOTA
- Postal Code
- 46939
- Country
- KR
- Correspondent
- Byung-wook Ha
US Agent
- Business Name
- LK Consulting Group USA, Inc.
- Contact Name
- Priscilla Chung
- Address
- 18881 Von Karman Ave STE 160
- City
- Irvine
- State
- CA
- ZIP
- 92612
- Country
- US
- [email protected]
- Phone
- 714 2025789
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2011-06-07 |
Proprietary Names
Soft Knee Brace ACL
Soft Knee Brace MCL
Knee Brace Cadena ROM
Knee Brace ROM
Soft Knee Brace PCL
Knee Immobilizer
Knee Brace G5 ROM
Knee Brace OM ROM
Knee Brace G3 ROM
Establishment Types
Manufacture Medical Device