# K183579: Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kits

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Neuromodulation
- Decided: Mar 29, 2019 after 98 days
- Product code: GZF (Stimulator, Peripheral Nerve, Implanted (Pain Relief))
- Device class: 2
- Regulation: 21 CFR 882.5870
- 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: 7 generations back to K883780 (1988). 10 ancestors in all.
6 later devices descend from it; 5 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171366: Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit, Stimwave Technologies Inc., Dba Stimq, LLC (2017) Summary page 4.

## Most influential descendants
- K202781: Neuspera Neurostimulation System (NNS) (2021), 1 descendant of its own
- K243782: StimTrial Neuromodulation System (2025), 0 descendants of its own
- K243678: TalisMann Neuromodulation System (2025), 0 descendants of its own
- K232415: Nalu Neurostimulation System for Peripheral Nerve Stimulation (2024), 0 descendants of its own
- K221303: Neuspera Nuity System (2023), 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
This system is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent or as an adjunct to other modes of therapy used in a multidisciplinary approach. The system is not intended to treat pain in the craniofacial region. 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/K183579
Methodology: https://510kreport.com/methodology