FDA Registration
Active
🇨🇳 China
FORTUNE COMPANY LTD.
Reg #: 3013198248
·
FEI: 3013198248
·
Expires 2026
Products
23
Proprietary Names
34
Establishment Types
2
Classifications
23
Registration Details
- Registration Name
- FORTUNE COMPANY LTD.
- Registration Number
- 3013198248
- FEI Number
- 3013198248
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Xintang Section, Xihu Village, Quichang Subdistrict, Huiyang District
- City
- Huizhou Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- Fortune Company Ltd.
- Operator Number
- 10056738
- Address
- Xintang Section, Xihu Village, Quichang Subdistrict, Huiyang District
- City
- Huizhou
- State
- Guangdong
- Postal Code
- 516221
- Country
- CN
- Correspondent
- Red Cheng
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Joint, Elbow, External Limb Component, Powered | IRE | Class 1 | Physical Medicine | No | 2018-01-13 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2021-06-25 |
| Walker, Mechanical | ITJ | Class 1 | Physical Medicine | No | 2018-01-13 |
| Accessories, Wheelchair | KNO | Class 1 | Physical Medicine | No | 2020-03-20 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2018-01-13 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2018-01-13 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2018-01-13 |
| Joint, Hip, External Brace | ITS | Class 1 | Physical Medicine | No | 2018-01-13 |
| Joint, Shoulder, External Limb Component | IQQ | Class 1 | Physical Medicine | No | 2018-01-13 |
| Hand, External Limb Component, Powered | IQZ | Class 1 | Physical Medicine | No | 2018-01-13 |
| Component, External, Limb, Ankle/Foot | ISH | Class 1 | Physical Medicine | No | 2018-01-13 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2018-01-13 |
| Cushion, Flotation | KIC | Class 1 | Physical Medicine | No | 2020-03-20 |
| Strap, Head, Gas Mask | BTK | Class 1 | Anesthesiology | No | 2018-01-13 |
| Cage, Knee | ITM | Class 1 | Physical Medicine | No | 2018-01-13 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2018-01-10 |
| Sling, Arm, Overhead Supported | ILE | Class 1 | Physical Medicine | No | 2018-01-13 |
| Support, Arm | IOY | Class 1 | Physical Medicine | No | 2018-01-13 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2018-01-13 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2018-01-13 |
| Apparatus, Traction, Non-Powered | HST | Class 1 | Orthopedic | No | 2018-01-13 |
| Splint, Clavicle | IQJ | Class 1 | Physical Medicine | No | 2018-01-13 |
| Orthosis, Foot Drop | OHI | Class 1 | Physical Medicine | No | 2018-01-13 |
Proprietary Names
JOINT, ELBOW, EXTERNAL LIMB COMPONENT, POWERED
Pack, Hot Or Cold, Reusable
WALKER, MECHANICAL
ACCESSORIES, WHEELCHAIR
ANKLE BRACE & SUPPORT, models of A01, A02, A03, A04, A05, A06, A07, A08, A09,A10
ANKLE BRACE & SUPPORT, models of A21, A22, A23, A24, A25, A26, A27, A28, A29,A30,A31,A32, A33
ANKLE BRACE & SUPPORT, models of A11, A12, A13, A14, A15, A16, A17, A18, A19,A20
Spinal brace/lumbo, models of B01, B02, B03, B04, B05, B06, B07, B08, B09,B10,B11, B12, B13
Spinal brace/lumbo, models of B14, B15, B16, B17, B18, B19, B20, B21, B22,B23,B24, B25, B26
Spinal brace/lumbo, models of B27, B28, B29, B30, B31, B32, B33, B34, B35,B36,B37, B38, B39
ORTHOSIS, LIMB BRACE
JOINT, HIP, EXTERNAL BRACE
JOINT, SHOULDER, EXTERNAL LIMB COMPONENT
HAND, EXTERNAL LIMB COMPONENT, POWERED
COMPONENT, EXTERNAL, LIMB, ANKLE/FOOT
SLING, ARM
CUSHION, FLOTATION
STRAP, HEAD, GAS MASK
CAGE, KNEE
Collar, models of N01, N02,N03, N04, N05, N06, N07, N08, N09, N10, N11, N12, N13, n14, N15, N16
SLING, ARM, OVERHEAD SUPPORTED
SUPPORT, ARM
Knee brace, Models of K21, K22, K23, K24, K25, K26, K27, K28, K29, K30, K31, K32, K33, K34, K35, K36, K37, K38,K39, K40
Hip brace, Models of T01, T02, T03, T04
Knee brace, Models of K01, K02, K03, K04, K05, K06, K07, KO8, K09, K10, K11, K12, K13, K14, K15, K16, K17, K18,K19, K20
Knee brace, Models of K41, K42, K43, K44, K45, K46, K47, K48, K09, K50
Wristorthosis, Models of W16, W17, W18, W19, W20, W21, W22, W23, W25, W26, W27, W28, W29, W30, W24
Finger orthosis,models of M16, M17, M18, M19, M20, M21, M22, M23, M25, M26, M27, M28, M29, M30, M24
Hand orthosis, models of H01, H02, H03, H04, H05, H06, H07, HO8, H09, H10, H11, H12, H13, H14, H15, H16, H17, H18
Wristorthosis, Models of W01, W02, W03, W04, W05, W06, W07, W08, W09, W10, W11, W12, W13, W14, W15
Finger orthosis,models of M01, M02, M03, M04, M05, M06, M07, M08, M09, M10, M11, M12, M13, M14, M15
Apparatus, traction, non-powered
SPLINT, CLAVICLE
Orthosis, foot drop
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device