ProlivRx System
FDA premarket approval P250010 · decided 2025-12-31
Approval details
- PMA number
- P250010
- Trade name
- ProlivRx System
- Generic name
- Cranial electrotherapy stimulator to treat depression
- Applicant
- Neurolief , Ltd.
- Date received
- 2025-03-26
- Decision date
- 2025-12-31
- Days to decision
- 280 days
- Decision code
- APPR
- Product code
- JXK
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Netanya
- Statement
- The ProlivRx System provides focal external Combined Occipital and Trigeminal Afferent Stimulation (eCOT-AS) treatment. It is intended as an adjunctive treatment for Major Depressive Disorder (MDD) in adults who failed to achieve satisfactory improvement from at least one previous antidepressant medication, for use at home or in clinic. It is a prescription-only device.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Relivion (K212106) | Neurolief , Ltd. | 2021-08-02 |
| Relivion (K203419) | Neurolief , Ltd. | 2021-02-16 |