Data / Medical devices / Israel / NEUROLIEF Ltd.
NEUROLIEF Ltd.: FDA-registered device maker in Netanya Central, Israel, 2 510(k) clearances and 1 PMA approval
NEUROLIEF Ltd. is registered with the FDA (registration 3015088397) in Netanya Central, Israel. It lists 2 device types. The FDA files 2 510(k) clearances 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
- 3015088397
- Address
- 12 Giborei Israel, Netanya Central, Israel, 4250412
- Owner or operator
- Neurolief (10081665)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer
- First device listed
- May 18, 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, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Stimulator, Nerve, Electrical, Transcutaneous, For Migraine | PCC | 2 | Complaint file establishment, Exporter to the US, Manufacturer | 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 |
| February 16, 2021 | K203419 | 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.