Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimu…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K183579 FDA 510(k)
- FDA Product Code
- GZF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5870 FDA 510(k)
- Regulation Number
- 882.5870 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Nalu Neurostimulation Kit is a peripheral nerve stimulator, implanted for pain relief. It delivers electrical stimulation via an implantable pulse generator (IPG) and leads to target peripheral nerves, addressing chronic focal neuropathic pain through neuromodulation.
The system includes integrated or ported IPGs with 40 cm or 2 cm lead configurations, single or dual electrode options, and trial/extension lead kits. Supplied sterile and intended for single-use, it is regulated under FDA 510(k) clearance (K183579) and classified as a Class II device (GZF). Components are designed for surgical implantation, with lead lengths specified for precise nerve targeting.
Frequently asked questions
What types of pain conditions is the Nalu Neurostimulation Kit designed to address specifically?
The Nalu Neurostimulation Kit is designed to target chronic focal neuropathic pain by delivering neuromodulation via an implanted peripheral nerve stimulator. It is not intended for generalized pain or conditions beyond peripheral nerve-related pain, such as post-surgical or post-traumatic neuropathies.
Are the leads in the Nalu Neurostimulation Kit reusable, or are they intended for single-use only?
The Nalu Neurostimulation Kit components, including the leads, are supplied sterile and intended for single-use only. This ensures patient safety and reduces the risk of infection or cross-contamination, as they are designed for surgical implantation.
What are the available lead lengths and configurations for the Nalu Neurostimulation Kit, and how do they differ?
The kit offers two primary lead lengths: 40 cm (integrated or ported IPG configurations) and 2 cm (ported IPG only). The 40 cm leads are designed for deeper nerve targeting, while the 2 cm leads are typically used in ported systems for more localized or superficial nerve access. Both configurations include single 8-electrode and dual 8-electrode options to accommodate different clinical needs.
How is the Nalu Neurostimulation Kit regulated in the U.S., and what does this mean for clinicians?
The Nalu Neurostimulation Kit holds FDA 510(k) clearance (K183579) under the classification of a Class II device (GZF). This means it has undergone review by the FDA’s Neurology (NE) advisory committee and is deemed substantially equivalent to a legally marketed predicate device. Clinicians can rely on this clearance as evidence of its safety and effectiveness for the intended use of peripheral nerve stimulation for chronic focal neuropathic pain.
What does the term ‘ported’ mean in the context of the Nalu Neurostimulation Kit, and how does it differ from the ‘integrated’ version?
The ported version of the Nalu Neurostimulation Kit features an implantable pulse generator (IPG) that is surgically connected to an external port, allowing for lead adjustments or replacements without removing the entire IPG. In contrast, the integrated version combines the IPG and leads into a single unit, simplifying implantation but limiting flexibility for future modifications. The ported design is particularly useful when multiple lead revisions or extensions may be needed.
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: Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu ..., Nalu™ System | Peripheral Nerve Stimulation (PNS) - Boston Scientific, Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K183579 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Boston Scientific Neuromodulation
Sources (1)
- FDA 510(k) K183579 24 fields · synced Sep 19, 2026