PMA P250010
- Device
- Proliv™Rx System
- Applicant
- Neurolief , Ltd.
- PMA number
- P250010
- Product code
- JXK
- Decision date
- 2025-12-31
- Classification
- Neurology
- Generic name
- Cranial electrotherapy stimulator to treat depression
- Approval order statement
- The Proliv™Rx 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.
Current openFDA PMA Record#
- Device
- Proliv™Rx System
- Applicant
- Neurolief , Ltd.
- PMA number
- P250010
- Product code
- JXK
- Generic name
- Cranial electrotherapy stimulator to treat depression
- Decision date
- 2025-12-31
- Decision code
- APPR
- Date received
- 2025-03-26
- Approval order statement
- The Proliv™Rx 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.