Data / Medical devices / United States / NEUROLIEF Inc.
NEUROLIEF Inc.: FDA-registered device maker in Coral Springs, FL, United States, 1 510(k) clearance and 1 PMA approval
NEUROLIEF Inc. is registered with the FDA (registration 3019551144) in Coral Springs, FL, United States. It lists 2 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated December 31, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3019551144
- Address
- 10211 W Sample Road #109, Coral Springs, FL, United States, 33065
- Owner or operator
- Neurolief (10081665)
- Roles
- Complaint file establishment
- First device listed
- August 10, 2021
- Registered through
- 2026
- Brand names listed
- ProlivRx System, ProlivRx external Combined Occipital and Trigeminal Afferent Stimulation (eCOT-AS), Relivion
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cranial Electrotherapy Stimulator To Treat Depression | JXK | 3 | Complaint file establishment | accessdata.fda.gov |
| Stimulator, Nerve, Electrical, Transcutaneous, For Migraine | PCC | 2 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| August 2, 2021 | K212106 | Relivion | PCC | Substantially Equivalent | Neurolief , Ltd. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| December 31, 2025 | P250010 | ProlivRx System | JXK | 0 | December 31, 2025 | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
- All makers of Cranial Electrotherapy Stimulator To Treat Depression
Updated December 31, 2025. 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.