Neurolief , Ltd.: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Neurolief , Ltd.” (first 2021, latest 2021), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 58 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 2 | 58 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Neurolief , Ltd. took a median 58 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 115 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PCC | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine | 2 | 2 |
| JXK | Cranial Electrotherapy Stimulator To Treat Depression | 1 | 0 |
Review panels
- Neurology (3)
Most recent Neurolief , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K212106 | Relivion | PCC | 2021-08-02 | 27 |
| K203419 | Relivion | PCC | 2021-02-16 | 89 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P250010 | PMA | ProlivRx System | 2025-12-31 |
Recalls
openFDA lists no recalls under a recalling firm named Neurolief , Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Neurolief , Ltd. is the lead sponsor of 5 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04279522: The MOOD Study - External Combined Occipital and Trigeminal Nerve Stimulation (eCOT-NS) for the Treatment of Major Depressive Disorder (MDD) (Completed, started 2021-08-31)
- NCT03631550: The RIME Study - Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation for Treatment of Migraine (Completed, started 2018-11-29)
- NCT03398668: Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation for Treatment of Migraine (Completed, started 2018-02-22)
- NCT02805881: Safety and Feasibility of Combined Trigeminal and Occipital Transcutaneous Nerve Stimulation (CTO-TNS) in Major Depressive Disorder (MDD) (Completed, started 2016-05)
- NCT02438553: Short-term Effectiveness of Transcutaneous Nerve Stimulation in Reducing Migraine Related Pain (Completed, started 2015-05)
Frequently asked questions
How many FDA 510(k) clearances are listed under Neurolief , Ltd.?
FDA lists 2 510(k) clearances under the applicant name “Neurolief , Ltd.” (first 2021, latest 2021), plus 1 PMA decision, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Neurolief , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Neurolief , Ltd. is 58 days.
Which FDA product codes appear under Neurolief , Ltd.?
The most frequent FDA product codes under this applicant name are PCC (Stimulator, Nerve, Electrical, Transcutaneous, For Migraine, 2); JXK (Cranial Electrotherapy Stimulator To Treat Depression, 1).
Next steps
- See all 2 Neurolief , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code PCC, Neurolief , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.