FDA Registration
Active
🇨🇳 China
ORTHOTECH REHABILITATION CO., LTD.
Reg #: 3031606416
·
FEI: 3031606416
·
Expires 2026
Products
26
Proprietary Names
2
Establishment Types
2
Classifications
26
Registration Details
- Registration Name
- ORTHOTECH REHABILITATION CO., LTD.
- Registration Number
- 3031606416
- FEI Number
- 3031606416
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Building #1, No. 69 Xinyuan South Rd., Xinyang Industry Section, Haicang, Xiamen China.
- City
- Xiamen Fujian
- Country
- CN
Owner / Operator
- Firm Name
- Orthotech Rehabilitation Co., Ltd.
- Operator Number
- 10090883
- Address
- Building #1, No. 69 Xinyuan South Rd., Xinyang Industry Section, Haicang, Xiamen China.
- City
- Xiamen
- State
- Fujian
- Postal Code
- 361000
- Country
- CN
- Correspondent
- Ramon Tseng
US Agent
- Business Name
- ST&G USA Corporation
- Contact Name
- GLENN CHOI
- Address
- 2691 SATURN ST
- City
- Brea
- State
- CA
- ZIP
- 92821
- Country
- US
- [email protected]
- Phone
- 714 5240663
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cane, Safety Walk | KHY | Class 1 | Physical Medicine | No | 2024-06-03 |
| Band Or Belt, Pelvic Support | ISR | Class 1 | Physical Medicine | No | 2024-06-03 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2024-05-28 |
| Splint, Clavicle | IQJ | Class 1 | Physical Medicine | No | 2024-05-28 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2024-06-03 |
| Orthosis, Corrective Shoe | KNP | Class 1 | Physical Medicine | No | 2024-06-03 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2024-05-28 |
| Sling, Arm, Overhead Supported | ILE | Class 1 | Physical Medicine | No | 2024-05-28 |
| Orthosis, Truncal/Orthosis, Limb | MRI | Class 1 | Physical Medicine | No | 2024-06-03 |
| Device, Prosthesis Alignment | IQO | Class 1 | Physical Medicine | No | 2024-06-03 |
| Apparatus, Traction, Non-Powered | HST | Class 1 | Orthopedic | No | 2024-06-03 |
| Cage, Knee | ITM | Class 1 | Physical Medicine | No | 2024-06-03 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2024-06-03 |
| Cushion, Flotation | KIC | Class 1 | Physical Medicine | No | 2024-06-03 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2024-05-28 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2024-05-28 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2024-05-28 |
| Orthosis, Lumbo-Sacral | IPY | Class 1 | Physical Medicine | No | 2024-06-03 |
| Component, External, Limb, Ankle/Foot | ISH | Class 1 | Physical Medicine | No | 2024-06-03 |
| Orthosis, Truncal, For Dysmenorrhea | NJB | Class 1 | Physical Medicine | No | 2024-06-03 |
| Splint, Temporary Training | IQM | Class 1 | Physical Medicine | No | 2024-05-28 |
| Cane | IPS | Class 1 | Physical Medicine | No | 2024-06-03 |
| Joint, Knee, External Limb Component | ISY | Class 1 | Physical Medicine | No | 2024-06-03 |
| Orthosis, Cervical-Thoracic, Rigid | IQF | Class 1 | Physical Medicine | No | 2024-06-03 |
| Support, Arm | IOY | Class 1 | Physical Medicine | No | 2024-05-28 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2024-05-28 |
Proprietary Names
orthotech
ORTHOTECH
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device