FDA Registration
Active
🇺🇸 United States
Freedom PNS System: External Transmitter and Two Component Implanted Neurostimulator with Electrode Array and Receiver
Reg #: 3010676138
·
FEI: 3010676138
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- CURONIX LLC
- Registration Number
- 3010676138
- FEI Number
- 3010676138
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1310 Park Central Boulevard S
- City
- Pompano Beach
- State
- FL
- ZIP
- 33064
- Country
- US
Regulatory Submissions
- 510(k) Number
- K171366
Owner / Operator
- Firm Name
- Curonix LLC
- Operator Number
- 10087444
- Address
- 1310 Park Central Blvd S
- City
- Pompano Beach
- State
- FL
- Postal Code
- 33064
- Country
- US
- Correspondent
- Hailey Rooney
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Peripheral Nerve, Implanted (Pain Relief) | GZF | Class 2 | Neurology | No | 2023-02-28 |
Proprietary Names
Freedom PNS System: External Transmitter and Two Component Implanted Neurostimulator with Electrode Array and Receiver
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device