FDA Registration
Active
🇺🇸 United States
Full-Body Freedom PNS System: External Transmitter & Two-Component 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
- K233162
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 | 2024-06-26 |
Proprietary Names
Full-Body Freedom PNS System: External Transmitter & Two-Component Neurostimulator with Electrode Array and Receiver
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device