Identity
- Trade Name
- ProlivRx System FDA PMA
- Generic Name
- Cranial electrotherapy stimulator to treat depression FDA PMA
Identifiers
- PMA Number
- P250010 FDA PMA
- FDA Product Code
- JXK FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Legislation / Framework
- 21 CFR Part 882.5800 FDA PMA
- Regulation Number
- 882.5800 FDA PMA
- Advisory Committee
- Neurology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The ProlivRx System is a Cranial Electrotherapy Stimulator designed to deliver focal external Combined Occipital and Trigeminal Afferent Stimulation (eCOT-AS). It is classified as a Class III device under FDA regulations and is intended for adjunctive treatment of Major Depressive Disorder (MDD) in adults who have not responded adequately to prior antidepressant therapy.
The device is supplied as a prescription-only system for use in either home or clinical settings. It is not described as single-use or reusable, and no sterility or MRI safety information is provided in the specifications. The ProlivRx System is authorized under FDA PMA (P250010) and falls under the product code JXK, with registration numbers 3019551144, 3015088397, and 3040334342.
Frequently asked questions
What is the primary clinical use of the ProlivRx System, and who is it intended for?
The ProlivRx System is a **Class III** cranial electrotherapy stimulator intended **only as an adjunctive treatment for Major Depressive Disorder (MDD)** in adults who have not responded adequately to prior antidepressant therapy. It is **not a standalone treatment** and requires prescription authorization for use in either home or clinical settings.
Is the ProlivRx System designed for single-use or repeated use, and what does that mean for maintenance?
The ProlivRx System is **not specified as single-use or reusable** in the provided data, meaning it is intended for **repeated use** over extended treatment periods. Since no sterility or cleaning instructions are mentioned, users should follow manufacturer guidelines (if available) to ensure proper maintenance and hygiene for ongoing therapy.
How is the ProlivRx System authorized for use in the U.S., and what regulatory pathway was followed?
The ProlivRx System is authorized under the **FDA’s Premarket Approval (PMA) pathway**, with the approval number **P250010**. This classification (Class III) requires rigorous clinical evidence to demonstrate safety and effectiveness, as it is intended for a significant health condition like MDD in adults who have failed prior treatments. The product code **JXK** and registration numbers (e.g., 3019551144) confirm its regulatory filing status.
Can the ProlivRx System be used in both clinical and home settings, and are there any restrictions?
Yes, the ProlivRx System is **explicitly authorized for use in both home and clinical settings** under prescription supervision. However, since it is **prescription-only**, administration must comply with healthcare provider guidelines, and patients must meet the criteria of having inadequate response to prior antidepressant therapy for adjunctive use.
What type of stimulation technology does the ProlivRx System use, and how does it differ from other cranial stimulation devices?
The ProlivRx System delivers **focal external Combined Occipital and Trigeminal Afferent Stimulation (eCOT-AS)**, targeting specific neural pathways associated with mood regulation. Unlike broader cranial stimulation methods, this approach focuses on **occipital and trigeminal nerve afferents**, which may offer a more targeted adjunctive treatment for MDD in resistant patients. The exact mechanism differs from non-invasive brain stimulation devices like tDCS or tACS.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P250010 | Class III | Active |
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Manufacturer
- Manufacturer
- Neurolief , Ltd.
Sources (1)
- FDA PMA P250010 23 fields · synced Sep 18, 2026