Data / Medical devices / United States / Nalu Medical
Nalu Medical: FDA-registered device maker in Carlsbad, CA, United States, 1 510(k) clearance
Nalu Medical is registered with the FDA (registration 3015425075) in Carlsbad, CA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 23, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3015425075
- Address
- 2320 Faraday Ave. Suite 100, Carlsbad, CA, United States, 92008
- Owner or operator
- Boston Scientific Corporation (9912058)
- Roles
- Manufacturer, Specification developer
- First device listed
- February 26, 2026
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stimulator, Peripheral Nerve, Implanted (Pain Relief) | GZF | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Stimulator, Spinal-Cord, Implanted (Pain Relief) | GZB | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 23, 2024 | K233801 | Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation | GZB | Substantially Equivalent | Boston Scientific Neuromodulation | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 3, 2024 | 94682 | Class II | Ongoing | Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm), REF: 71019-US Components of the Nalu Spinal Cord Stimulation System. | Neurostimulation Systems have a manufacturing non-conformance that may reduce the efficiency of the radiofrequency signals between the Implantable Pulse Generator (IPG) and the Therapy Disc, causing the IPG to be non-functional, which causes the device to be non-functional so it will no longer inhibit the transmission of pain signals to the brain. | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Peripheral Nerve, Implanted (Pain Relief)
- All makers of Stimulator, Spinal-Cord, Implanted (Pain Relief)
Updated August 23, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.