Nalu Medical

Carlsbad, CA, US

NALU MEDICAL appears in FDA device records in Carlsbad, CA. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 1
PMA records: 0
Recall records: 1
Registered establishments: 1

510(k) clearance history

FDA records hold 1 510(k) clearance for Nalu Medical in 2019.

Clearances by year, as a table

510(k) clearance decisions for Nalu Medical, by decision year
Year	Clearances
2019	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K191435	IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4	GZF	Substantially Equivalent	2019-09-06

Registered establishments

FDA registered establishments for Nalu Medical, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3015425075	3015425075	NALU MEDICAL	2320 Faraday Ave., Carlsbad, CA 92008 US	2026	GZB GZF

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-2257-2024	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.	Class II	2024-06-03	Open, Classified

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain