FDA Registration
Active
🇨🇳 China
XIAMEN ORTOCARE SPORTS HEALTH CO.,LTD.
Reg #: 3012841710
·
FEI: 3012841710
·
Expires 2026
Products
32
Proprietary Names
34
Establishment Types
2
Classifications
32
Registration Details
- Registration Name
- XIAMEN ORTOCARE SPORTS HEALTH CO.,LTD.
- Registration Number
- 3012841710
- FEI Number
- 3012841710
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Office 218, New Times Building, NO.1 Huli Avenue, Huli District
- City
- Xiamen Free Trade Zone Fujian
- Country
- CN
Owner / Operator
- Firm Name
- XIAMEN ORTOCARE SPORTS HEALTH CO.,LTD.
- Operator Number
- 10056512
- Address
- Office 218, New Times Building, NO.1 Huli Avenue, Huli District
- City
- Xiamen Free Trade Zone
- State
- Fujian
- Postal Code
- 361006
- Country
- CN
- Correspondent
- Xinjie Shao
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.,
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cover, Limb | IPM | Class 1 | Physical Medicine | No | 2024-12-12 |
| Gown, Examination | FME | Class 1 | General Hospital | No | 2020-03-26 |
| Exerciser, Powered | BXB | Class 1 | Physical Medicine | No | 2021-12-18 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2020-03-26 |
| Orthosis, Cervical | IQK | Class 1 | Physical Medicine | No | 2017-12-21 |
| Support, Arm | IOY | Class 1 | Physical Medicine | No | 2017-12-21 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2017-12-21 |
| Orthosis, Corrective Shoe | KNP | Class 1 | Physical Medicine | No | 2017-12-21 |
| Adaptor, Hygiene | ILS | Class 1 | Physical Medicine | No | 2024-07-25 |
| Cane | IPS | Class 1 | Physical Medicine | No | 2020-12-15 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2017-12-21 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2018-12-17 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2017-12-18 |
| Shield, Protective, Personnel | KPY | Class 1 | Radiology | No | 2020-03-26 |
| Mattress, Air Flotation, Alternating Pressure | FNM | Class 2 | General Hospital | No | 2021-12-18 |
| Wound Dressing Kit | MCY | Class 2 | General Hospital | No | 2024-07-25 |
| Splint, Clavicle | IQJ | Class 1 | Physical Medicine | No | 2024-12-12 |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | NOC | Class 1 | General, Plastic Surgery | No | 2017-12-21 |
| Bed, Ac-Powered Adjustable Hospital | FNL | Class 2 | General Hospital | No | 2021-12-18 |
| Chair, Adjustable, Mechanical | INN | Class 1 | Physical Medicine | No | 2020-12-15 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2017-12-21 |
| Cover, Cast | KIA | Class 1 | General Hospital | No | 2024-07-25 |
| Pack, Hot Or Cold, Water Circulating | ILO | Class 2 | Physical Medicine | No | 2019-12-15 |
| Board, Scooter, Prone | KNL | Class 1 | Physical Medicine | No | 2018-12-17 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2017-12-21 |
| Chair, With Casters | INM | Class 1 | Physical Medicine | No | 2020-12-15 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2017-12-21 |
| Mask, Scavenging | KHA | Class 1 | Anesthesiology | No | 2020-03-12 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-03-26 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2018-12-17 |
| Joint, Hip, External Brace | ITS | Class 1 | Physical Medicine | No | 2017-12-21 |
| Sling, Arm, Overhead Supported | ILE | Class 1 | Physical Medicine | No | 2017-12-21 |
Proprietary Names
Prosthetic Joint
Disposable gown
Physical therapy device
Medical Disposable goggle
CERVICAL COLLARS
ELBOW BRACES
FINGER SPLINTS
WRIST BRACES
POST OP SHOES
shower chair
Crutch,walking stick
KNEE BRACES, GOAT
Air pressure massager, leg massager, knee massager, back massager,neck massager
ORTHOPEDIC BRACES, Posture correction device
Protective Eye Shield
Medical mattress
wound care kit
Clavical Brace
NIGHT SPLINTS
Medical bed
Toilet chair
WALKER BRACES
ANKLE BRACES
waterproof cast dressing cover
HOT/COLD,WATER CIRCULATING,COLD THERAPY DEVICE
knee scooter
BACK BRACK BRACES
patient transfer equipment
ARM SLINGS
face mask
Isolation Suit
hot/cold therapy products
HIP BRACES
SHOULDER SLINGS, Kangaroo Shoulder Sling KSS001,Kahuna Brace KB001,Mini Kahuna Brace MKB001
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)