# K183047: Nalu Neurostimulation System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Neuromodulation
- Decided: Mar 22, 2019 after 140 days
- Product code: GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief))
- Device class: 2
- Regulation: 21 CFR 882.5880
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K883780 (1988). 8 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170141: Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit, Stimwave Technologies Incorporated (2017) Summary page 4.

## Most influential descendants
- K201618: Nalu Neurostimulation SCS system (2020), 3 descendants of its own
- K203547: Nalu Neurostimulation System (2021), 2 descendants of its own
- K221376: Nalu Neurostimulation System (2022), 1 descendant of its own
- K233801: Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation (2024), 0 descendants of its own
- K202274: Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kits (2020), 0 descendants of its own

## Recalls of this device
- Jun 3, 2024 · Class II · Z-2257-2024: 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 t

## Indications for use
The Nalu Neurostimulation System is indicated as the sole mitigating agent or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain. The trial devices are solely used for trial stimulation (no longer thank 30 days) to determine efficacy before recommendation for a permanent (long term) device.

Source page: https://510kreport.com/device/K183047
Methodology: https://510kreport.com/methodology