# K152178: StimQ Peripheral Nerve Stimulator (PNS) System

- Pathway: 510(k) (Traditional)
- Applicant: Stimq, LLC
- Decided: Mar 11, 2016 after 220 days
- Product code: GZF (Stimulator, Peripheral Nerve, Implanted (Pain Relief))
- Device class: 2
- Regulation: 21 CFR 882.5870
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K883780 (1988). 5 ancestors in all.
10 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150517: Freedom Spinal Cord Stimulator System, Stimwave Technologies Incorporated (2015) Summary page 4.
- K141399: Freedom Spinal Cord Stimulator (SCS) System, Stimwave Technologies Incorporated (2014) Summary page 4.
- K934065: Medtronic Mattrix 3271/3272 Neurostimulation System, Medtronic Vascular (1995) Summary page 4.
- K883780: Xtrel, Model Number 3425, Medtronic Vascular (1988) Summary page 4.
- K000852: Renew Neurostimulation System, Advanced Neuromodulation Systems (2001) Summary page 4.

## Most influential descendants
- K171366: Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit (2017), 9 descendants of its own
- 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 (2019), 6 descendants of its own
- 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

## Recalls of this device
- Jul 15, 2020 · Class II · Z-2929-2020: The product contains a non-functional component not referenced in product labeling.
- Jul 15, 2020 · Class II · Z-2930-2020: The product contains a non-functional component not referenced in product labeling.
- Jul 15, 2020 · Class II · Z-2933-2020: The product contains a non-functional component not referenced in product labeling.
- Jul 15, 2020 · Class II · Z-2931-2020: The product contains a non-functional component not referenced in product labeling.
- Jul 15, 2020 · Class II · Z-2932-2020: The product contains a non-functional component not referenced in product labeling.
- Jul 15, 2020 · Class II · Z-2928-2020: The product contains a non-functional component not referenced in product labeling.

## Indications for use
The StimQ Peripheral Nerve Stimulator (PNS) 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 StimQ PNS System is not intended to treat pain in the craniofacial region. The StimQ Trial Lead Kit is only used in conjunction with the StimQ Stimulator Receiver Kit. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.

Source page: https://510kreport.com/device/K152178
Methodology: https://510kreport.com/methodology