FDA Registration
Active
🇺🇸 United States
TrackX Cap and Collar
Reg #: 3021559833
·
FEI: 3021559833
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- WHEELHOUSE MEDICAL
- Registration Number
- 3021559833
- FEI Number
- 3021559833
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 511 Jim Parker Rd
- City
- Monroe
- State
- NC
- ZIP
- 28110
- Country
- US
Regulatory Submissions
- 510(k) Number
- K200360
Owner / Operator
- Firm Name
- WHEELHOUSE MEDICAL
- Operator Number
- 10084227
- Address
- 511 Jim Parker Rd
- City
- Monroe
- State
- NC
- Postal Code
- 28110
- Country
- US
- Correspondent
- John Souza Souza
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2024-10-21 |
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2024-10-21 |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2024-10-21 |
Proprietary Names
TrackX Cap and Collar
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)