FDA Registration
Active
🇻🇳 Vietnam
RUITAI OUTDOOR EQUIPMENT CO., LTD
Reg #: 3030175335
·
FEI: 3030175335
·
Expires 2026
Products
6
Proprietary Names
16
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- RUITAI OUTDOOR EQUIPMENT CO., LTD
- Registration Number
- 3030175335
- FEI Number
- 3030175335
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- MR. Nguyen Dinh Quans House, To Ho Village
- City
- PHU DUC COMMUNE Hung Yen
- Country
- VN
Owner / Operator
- Firm Name
- RUITAI OUTDOOR EQUIPMENT CO., LTD
- Operator Number
- 10089165
- Address
- MR. NGUYEN DINH QUAN'S HOUSE, TO HO VILLAGE
- City
- PHU DUC COMMUNE
- State
- Hung Yen
- Postal Code
- none
- Country
- VN
US Agent
- Business Name
- Registrar Corp.
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Support, Arm | IOY | Class 1 | Physical Medicine | No | 2025-04-25 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2023-11-09 |
| Orthosis, Lumbar | IQE | Class 1 | Physical Medicine | No | 2025-04-25 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2025-04-25 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2025-04-25 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2025-04-25 |
Proprietary Names
Shoulder Abduction Sling: 59015, Shoulder Immobilizer:59025
WALKER-10002,10003,10005,10007,10008,10002RED,10003RED,10005RED, 10007RED,10008RED,10002BLU,10003BLU,10005BLU,10007BLU,
11008,11102,11103,11105,11107,11108,11002RED,11003RED,11005RED,11007RED,11008RED,11002BLU,11003BLU,11005BLU,11005BLU,11007BLU11008BLU
10008BLK,10102,10103, 10105, 10107, 10108, 10102RED,10103RED, 10105RED,10107RED,10108RED,10102BLU
10103BLU,10105BLU,10107BLU, 10108BLU,10102BLK,10103BLK,10105BLK,10107BLK,10108BLK,11002,11003,11005,11007
VP10627-000, VP10631-000, VP10637-000, VP10600-000 Lumbar support
Back Brace: 61001, 61002, 61003, 61004, 61007, 61008, 61000
tep-free ankle stabilizer: 22003, 22005, 22007
Ankle Stirrup: 2000W, 2000B, 2020B, 2020W, 2100B, 2100W Hybrid night splint
50072-2, 50075-2, 50078-2, 51072-2, 51075-2, 51078-2
boxer fracture splint: 51080, 50080
wrist/thumb brace: 58072-2,58075-2, 58078-2, 59072-2, 59075-2, 59078-2
45017, 45018, 45019, 45023, 45025, 45027, 45028, 45029, 45030, 45031
OA Knee Brace: 49001, 49002, 4900-WR, 4900-KEY, 4900-BS-2, 4900-FS, 4900-LL-2
Neoprene Knee Support:45003, 45005, 45007, 45008, 45009, 45013
4900-LR-2, 4900-SK, 100630-100,100630-200,100678-000, 100689-100
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device