# K150517: Freedom Spinal Cord Stimulator System

- Pathway: 510(k) (Traditional)
- Applicant: Stimwave Technologies Incorporated
- Decided: Jun 5, 2015 after 95 days
- Product code: GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief))
- Device class: 2
- Regulation: 21 CFR 882.5880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K883780 (1988). 4 ancestors in all.
23 later devices descend from it; 3 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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
- K160600: Freedom Spinal Cord Stimulator System (2016), 21 descendants of its own
- K162161: Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit (2016), 20 descendants of its own
- K170141: Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit (2017), 19 descendants of its own
- K152178: StimQ Peripheral Nerve Stimulator (PNS) System (2016), 10 descendants of its own
- K171366: Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit (2017), 9 descendants of its own

## Indications for use
The Freedom Spinal Cord Stimulator (SCS) System is intended 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 lower limbs, including unilateral or bilateral pain. The Freedom-8A Trial Lead Kit is only used in conjunction with the Freedom-8A Stimulator Receiver Kit, and the Freedom-4A Trial Lead Kit is used for either the Receiver Kit Freedom-4A Stimulator or the Receiver Kit Freedom-8A Stimulator. 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/K150517
Methodology: https://510kreport.com/methodology