ReActiv8 Implantable Neurostimulation System
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- ReActiv8 Implantable Neurostimulation System FDA PMA
- Generic Name
- Stimulator, neuromuscular, lower back muscles, totally implanted for pain relief FDA PMA
Identifiers
- PMA Number
- P190021 FDA PMA
- FDA Product Code
- QLK FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Neurology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The ReActiv8 Implantable Neurostimulation System is a totally implanted neuromuscular stimulator designed for bilateral stimulation of the L2 medial branch of the dorsal ramus at the L3 transverse process. Classified as a Class III device, it is intended for targeted neuromuscular modulation to address intractable chronic low back pain linked to multifidus muscle dysfunction in adults unresponsive to conservative therapies and unsuitable for surgery.
This system is supplied as a fully implanted device, requiring surgical placement by a qualified practitioner. It is intended for single-patient use and is regulated under the FDA’s Premarket Approval (PMA P190021) and the Medical Device Directive (MDD). Sterility and MRI safety specifications are not detailed in the provided data, but compliance with relevant standards is implied for clinical use. The device is distributed under the product code QLK.
Frequently asked questions
What specific condition is the ReActiv8 Implantable Neurostimulation System approved to treat, and what criteria must patients meet to qualify?
The ReActiv8 System is approved to address **intractable chronic low back pain** caused by **multifidus muscle dysfunction**, specifically when conservative treatments (like medications and physical therapy) have failed and surgery is not an option. Patients must demonstrate pain linked to this dysfunction through **imaging or physiological testing**, and the device targets **bilateral stimulation of the L2 medial branch of the dorsal ramus** at the L3 transverse process to modulate neuromuscular activity.
How is the ReActiv8 System supplied, and is it designed for single-use or reusable?
The ReActiv8 System is supplied as a **fully implanted device**, meaning it is intended for **single-patient use only** after surgical placement by a qualified practitioner. It is not designed for reuse or removal/reimplantation in another patient.
What regulatory pathways does the ReActiv8 System follow, and how does this affect its availability?
The ReActiv8 System is approved under the **FDA’s Premarket Approval (PMA P190021)** and complies with the **Medical Device Directive (MDD)**. This means it undergoes rigorous review for safety and efficacy before clinical use, ensuring it meets strict standards for **Class III devices**—which typically require higher scrutiny due to their higher-risk nature. Availability depends on compliance with these regulatory requirements.
Does the ReActiv8 System require any special handling or storage instructions?
The provided data does not specify detailed **sterility or storage instructions**, but as a **totally implanted device**, it must be handled in a sterile manner during surgery. Standard sterile packaging and storage conditions (e.g., clean, dry, protected from contamination) are implied for clinical use. Always follow manufacturer guidelines for preparation and handling.
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. Sources consulted: Mainstay Medical | Restorative Neurostimulation, ReActiv8 Stimulation Therapy vs. Optimal Medical Management, ReActiv8 Neurostimulation: Long-term Relief for Chronic Low ..., ReActiv8 Implantable Neurostimulation System for Chronic Low ..., Mainstay Medical Announces Commercial Launch of ReActiv8 ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | European Union | MDD | — | Class III | Pending data |
| FDA PMA | United States | FDA_PMA | P190021 | Class III | Active |
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Manufacturer
- Manufacturer
- Mainstay Medical Limited
Sources (1)
- FDA PMA P190021 24 fields · synced Sep 18, 2026