Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and …
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K161154 FDA 510(k)
- FDA Product Code
- NHI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5890 FDA 510(k)
- Regulation Number
- 882.5890 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Smartpatch Peripheral Nerve Stimulation (PNS) System is a percutaneous electrode placed via an introducer needle in proximity to a target peripheral nerve associated with a painful area and a wearable external stimulator that delivers stimulation therapy to the percutaneous electrode. It is indicated for up to 30 days in the back and/or extremities for symptomatic relief of chronic pain.
The system is supplied as a kit containing the Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs. It is authorized under FDA 510(k) clearance K161154, product code NHI, regulation number 882.5890, and is classified as a Class II device for nerve stimulation in neurology.
Frequently asked questions
What is the Smartpatch PNS System used for?
The Smartpatch PNS System is indicated for symptomatic relief of chronic pain in the back and/or extremities by delivering percutaneous peripheral nerve stimulation via an introducer needle-placed electrode and a wearable external stimulator for up to 30 days.
How is the Smartpatch PNS System supplied?
The system is supplied as a kit containing the Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, and Smartpatch PNS Pads in 4 Packs.
Is the Smartpatch PNS System intended for single use or reuse?
The Smartpatch PNS MicroLead is a percutaneous electrode designed for single-patient use over up to 30 days, while the wearable stimulator and pads may be reused during the treatment period as part of the system's intended use.
What are the storage requirements for the Smartpatch PNS System?
The device data does not specify storage conditions; users should refer to the manufacturer's labeling for proper storage instructions to maintain device integrity and sterility.
What regulatory pathway was used for the Smartpatch PNS System?
The Smartpatch PNS System was authorized under FDA 510(k) clearance K161154, with product code NHI and regulation number 882.5890, and is classified as a Class II device.
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: Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator ..., Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator ..., PDF Smartpatch PNS MicroLead And Accessories, Smartpatch PNS Stimulator ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161154 | Class II | Active |
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Manufacturer
- Manufacturer
- Spr Therapeutics, LLC
Sources (1)
- FDA 510(k) K161154 24 fields · synced Sep 28, 2026