PMA
P250010: Proliv™Rx System
FDA PMA · Cranial electrotherapy stimulator to treat depression · Neurolief, Ltd.
Key facts
| PMA number | P250010 |
|---|---|
| Trade name | Proliv™Rx System |
| Generic name | Cranial electrotherapy stimulator to treat depression |
| Applicant | Neurolief , Ltd. |
| Owner/operator | Neurolief |
| Product code | JXK |
| Approval date | Dec 31, 2025 |
| Establishment registration | 3015088397 |
| FEI number | 3015088397 |
At a glance
- None Supplements
- Dec 31, 2025 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: