# K141399: Freedom Spinal Cord Stimulator (SCS) System

- Pathway: 510(k) (Traditional)
- Applicant: Stimwave Technologies Incorporated
- Decided: Oct 10, 2014 after 135 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: 1 generation back to K883780 (1988). 3 ancestors in all.
24 later devices descend from it; 5 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)
- 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
- K150517: Freedom Spinal Cord Stimulator System (2015), 23 descendants of its own
- 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

## Indications for use
The Stimwave Technologies Incorporated 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 FRT4-A001 device is solely used for trial stimulation (no longer than 30 days) of the permanent FRE4-A001 device.

Source page: https://510kreport.com/device/K141399
Methodology: https://510kreport.com/methodology