FDA Registration
Active
🇨🇳 China
XIAMEN J-BRACE MEDICAL EQUIPMENT CO., LTD.
Reg #: 3008381107
·
FEI: 3008381107
·
Expires 2026
Products
24
Proprietary Names
21
Establishment Types
2
Classifications
24
Registration Details
- Registration Name
- XIAMEN J-BRACE MEDICAL EQUIPMENT CO., LTD.
- Registration Number
- 3008381107
- FEI Number
- 3008381107
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2F,179# Tongan Park, Tongan Industrial Concnetration Area
- City
- Xiamen Fujian
- Country
- CN
Owner / Operator
- Firm Name
- Xiamen J-Brace Medical Equipment Co., Ltd.
- Operator Number
- 10032276
- Address
- 2F79# Tongan Park, Tongan Industrial Concnetration Area
- City
- Xiamen
- State
- CN-NOTA
- Postal Code
- 361009
- Country
- CN
- Correspondent
- Li Zemei
US Agent
- Business Name
- Samorajczyk Regulatory Consultants, LLC
- Contact Name
- John Samorajczyk
- Address
- 5414 Leilani Drive
- City
- St Pete Beach
- State
- FL
- ZIP
- 33706
- Country
- US
- [email protected]
- Phone
- 727 4803810
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2018-03-20 |
| Respirator, Surgical | MSH | Class 2 | General, Plastic Surgery | No | 2020-03-25 |
| Orthosis, Truncal/Orthosis, Limb | MRI | Class 1 | Physical Medicine | No | 2010-04-28 |
| Exerciser, Powered | BXB | Class 1 | Physical Medicine | No | 2020-03-13 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2023-11-17 |
| Crutch | IPR | Class 1 | Physical Medicine | No | 2023-11-17 |
| Binder, Elastic | KMO | Class 1 | General Hospital | No | 2023-11-17 |
| Device, Transfer, Patient, Manual | FMR | Class 1 | General Hospital | No | 2023-11-17 |
| Stocking, Medical Support (For General Medical Purposes) | FQL | Class 1 | General Hospital | No | 2024-08-02 |
| Splint, Temporary Training | IQM | Class 1 | Physical Medicine | No | 2014-01-13 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2010-04-28 |
| Support, Hernia | EXN | Class 1 | Gastroenterology, Urology | No | 2020-10-07 |
| Band Or Belt, Pelvic Support | ISR | Class 1 | Physical Medicine | No | 2023-11-17 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2018-03-20 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2010-04-28 |
| Orthosis, Foot Drop | OHI | Class 1 | Physical Medicine | No | 2018-03-20 |
| Support, Arm | IOY | Class 1 | Physical Medicine | No | 2018-03-20 |
| Restraint, Protective | FMQ | Class 1 | General Hospital | No | 2020-10-07 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2010-04-28 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2010-04-28 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2018-03-20 |
| Orthosis, Abdominal | KTD | Class 1 | Physical Medicine | No | 2010-04-28 |
| Pack, Heat, Moist | IMA | Class 1 | Physical Medicine | No | 2020-10-07 |
| Joint, Hip, External Brace | ITS | Class 1 | Physical Medicine | No | 2023-11-17 |
Proprietary Names
Shoulder Braces Supports
surgical masks, respirators
J-Brace, Various Shoulder Braces, K
ANKLE MOTION
MANAMED
LENJOY MEDICAL ENGINEERING, INC
Dorsal Night Splint
J-Brace and various neck braces
Hernia support
Lumbar Support
Finger Brace, Finger Splint
Hand Brace
Foot Drop Orthosis
elbow and arm braces supports
protective restraint
Wrist Brace,
J-Brace arm brace, elbow brace, wri
Ankle Brace, Foot Brace,
Knee Brace
J-Brace Waist Braces, Lumbar/Spinal
moist heat pack
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device