FDA Registration
Active
🇨🇳 China
JIANGSU REAK HEALTHY ARTICLES CO.,LTD
Reg #: 3005157379
·
FEI: 3005157379
·
Expires 2026
Products
17
Proprietary Names
14
Establishment Types
2
Classifications
17
Registration Details
- Registration Name
- JIANGSU REAK HEALTHY ARTICLES CO.,LTD
- Registration Number
- 3005157379
- FEI Number
- 3005157379
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.1 Jiangzhou Square
- City
- Yangzhong City Jiangsu
- Country
- CN
Owner / Operator
- Firm Name
- Jiangsu Reak Healthy Articles Co.,Ltd
- Operator Number
- 9072998
- Address
- No.1 Jiangzhou Square
- City
- Yangzhong City
- State
- Jiangsu
- Postal Code
- 212200
- Country
- CN
US Agent
- Business Name
- Mansour Consulting LLC
- Contact Name
- Jay Mansour
- Address
- 845 Aronson Lake Ct
- City
- Roswell
- State
- GA
- ZIP
- 30075
- Country
- US
- [email protected]
- Phone
- 678 9088180
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2017-01-07 |
| Orthosis, Abdominal | KTD | Class 1 | Physical Medicine | No | 2017-01-07 |
| Orthosis, Truncal/Orthosis, Limb | MRI | Class 1 | Physical Medicine | No | 2007-06-12 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2017-03-21 |
| Joint, Hip, External Brace | ITS | Class 1 | Physical Medicine | No | 2005-05-11 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2005-05-11 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2025-06-26 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2018-06-12 |
| Support, Arm | IOY | Class 1 | Physical Medicine | No | 2005-05-11 |
| Adaptor, Dressing | ILD | Class 1 | Physical Medicine | No | 2015-12-16 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2005-05-11 |
| Tips And Pads, Cane, Crutch And Walker | INP | Class 1 | Physical Medicine | No | 2017-12-18 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2005-05-11 |
| Table And Attachments, Operating-Room | BWN | Class 1 | General, Plastic Surgery | No | 2017-03-21 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2023-08-03 |
| Sleeve, Limb, Compressible | JOW | Class 2 | Cardiovascular | No | 2012-08-31 |
| Apparatus, Traction, Non-Powered | HST | Class 1 | Orthopedic | No | 2021-08-09 |
Proprietary Names
ORTHOSIS, TRUNCAL/ORTHOSIS, LIMB
BODY SUPPORT
Armboard
MELANGE BRACES AND LIMP SUPPORT
SPLINT, HAND, AND COMPONENTS
MELANGE BRACES AND LIMP SUPPORTS
Protector, skin pressure
Dressing adaptor
JOINT, KNEE, EXTERNAL BRACE
Crutch, Grip & Underarm pillow
JOINT, ANKLE, EXTERNAL BRACE
Mouth and Jaw Pain Relief Wrap
ALP 501 Pump System Limb (ALP1-4) + ALP 501
Neck stretcher (Neck Hammock)
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)