FDA Registration
Active
🇺🇸 United States
528i 5i Series
Reg #: 3031075901
·
FEI: 3031075901
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- 528 INNOVATIONS LLC
- Registration Number
- 3031075901
- FEI Number
- 3031075901
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1405 Arrow Point Dr., Suite 1101
- City
- Cedar Park
- State
- TX
- ZIP
- 78613
- Country
- US
Owner / Operator
- Firm Name
- 528 Innovations LLC
- Operator Number
- 10090741
- Address
- 1320 Arrow Point Drive, Suite 303
- City
- Cedar Park
- State
- TX
- Postal Code
- 78613
- Country
- US
- Correspondent
- Kevin Johnson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2024-05-08 |
Proprietary Names
528i 5i Series
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility