# K233162: Freedom Peripheral Nerve Stimulator (PNS) System

- Pathway: 510(k) (Traditional)
- Applicant: Curonix
- Decided: Jun 20, 2024 after 267 days
- Product code: GZF (Stimulator, Peripheral Nerve, Implanted (Pain Relief))
- Device class: 2
- Regulation: 21 CFR 882.5870
- Recalls of this device: none
- 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.
No later device cites it as a predicate yet.
0 of 11 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 5.

## Indications for use
The Freedom 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 Freedom Trial Lead Kit is only to be used in conjunction with the Freedom Neurostimulator Kit. The trial devices are solely used for a trial stimulation period (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.

Source page: https://510kreport.com/device/K233162
Methodology: https://510kreport.com/methodology