Data / Medical devices / United States / Curonix LLC
Curonix LLC: FDA-registered device maker in Pompano Beach, FL, United States, 12 510(k) clearances
Curonix LLC is registered with the FDA (registration 3010676138) in Pompano Beach, FL, United States. It lists 2 device types. The FDA files 12 510(k) clearances under its listings, the newest dated June 20, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010676138
- Address
- 1310 Park Central Boulevard S, Pompano Beach, FL, United States, 33064
- Owner or operator
- Curonix LLC (10087444)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- February 28, 2023
- Registered through
- 2026
- Brand names listed
- Freedom PNS System: External Transmitter and Two Component Implanted Neurostimulator with Electrode Array and Receiver, Freedom Peripheral Nerve Stimulator (PNS) System, Freedom SCS System: External Transmitter and Two Component Implanted Neurostimulator with Electrode Array and Receiver, Freedom Spinal Cord Stimulator (SCS) System, Full-Body Freedom PNS System: External Transmitter & Two-Component Neurostimulator with Electrode Array and Receiver, Spinal Cord Stimulator (SCS) SandShark Injectable Anchor (SIA) Accessory
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stimulator, Peripheral Nerve, Implanted (Pain Relief) | GZF | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Stimulator, Spinal-Cord, Implanted (Pain Relief) | GZB | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 20, 2024 | K233162 | Freedom Peripheral Nerve Stimulator (PNS) System | GZF | Substantially Equivalent | Curonix | accessdata.fda.gov |
| November 7, 2019 | K191466 | SandShark Injectable Anchor (SIA) System | GZB | Substantially Equivalent | Stimwave Technologies, Inc. | accessdata.fda.gov |
| March 29, 2019 | K182720 | Freedom Spinal Cord Stimulator (SCS) System | GZB | Substantially Equivalent | Stimwave Technologies Incorporated | accessdata.fda.gov |
| September 19, 2018 | K180981 | Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit | GZB | Substantially Equivalent | Stimwave Technologies Incorporated | accessdata.fda.gov |
| November 3, 2017 | K172644 | Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base | GZB | Substantially Equivalent | Stimwave Technologies Incorporated | accessdata.fda.gov |
| August 4, 2017 | K171366 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit | GZF | Substantially Equivalent | Stimwave Technologies Inc., Dba Stimq, LLC | accessdata.fda.gov |
| May 2, 2017 | K170141 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit | GZB | Substantially Equivalent | Stimwave Technologies Incorporated | accessdata.fda.gov |
| December 16, 2016 | K162161 | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit | GZB | Substantially Equivalent | Stimwave Technologies Incorporated | accessdata.fda.gov |
| August 26, 2016 | K160600 | Freedom Spinal Cord Stimulator System | GZB | Substantially Equivalent | Stimwave Technologies Incorporated | accessdata.fda.gov |
| March 11, 2016 | K152178 | StimQ Peripheral Nerve Stimulator (PNS) System | GZF | Substantially Equivalent | Stimq, LLC | accessdata.fda.gov |
| June 5, 2015 | K150517 | Freedom Spinal Cord Stimulator System | GZB | Substantially Equivalent | Stimwave Technologies Incorporated | accessdata.fda.gov |
| October 10, 2014 | K141399 | FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM | GZB | Substantially Equivalent | Stimwave Technologies Incorporated | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 15, 2020 | 86115 | Class II | Ongoing | StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of periph | The product contains a non-functional component not referenced in product labeling. | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Peripheral Nerve, Implanted (Pain Relief)
- All makers of Stimulator, Spinal-Cord, Implanted (Pain Relief)
Updated June 20, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.