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FDA 510(k)

Freedom Spinal Cord Stimulator (SCS) System

K-Number: K182720 · 2019-03-29

ApplicantStimwave Technologies Incorporated
Decision Date2019-03-29
Product CodeGZB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Freedom Spinal Cord Stimulator (SCS) System is a medical device manufactured by Stimwave Technologies Incorporated. It received FDA 510(k) clearance on 2019-03-29 under approval number K182720. The device is classified under product code GZB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Freedom Spinal Cord Stimulator (SCS) System?

Freedom Spinal Cord Stimulator (SCS) System is a medical device that received FDA 510(k) clearance on 2019-03-29. It is manufactured by Stimwave Technologies Incorporated. The 510(k) number is K182720.

When was Freedom Spinal Cord Stimulator (SCS) System approved by the FDA?

Freedom Spinal Cord Stimulator (SCS) System received FDA 510(k) clearance on 2019-03-29, under approval number K182720.

What company makes Freedom Spinal Cord Stimulator (SCS) System?

Freedom Spinal Cord Stimulator (SCS) System is manufactured by Stimwave Technologies Incorporated.

What is the FDA product code for Freedom Spinal Cord Stimulator (SCS) System?

The FDA product code for Freedom Spinal Cord Stimulator (SCS) System is GZB.

Related Clinical Trials

NCT06998134 Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults RECRUITING NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT06087445 A User-friendly, Non-invasive Neuro-orthosis That Restores Volitionally Controlled Grasp Functions for SCI Survivors With Tetraplegia COMPLETED NCT00453505 Modulation of Motor Function by Stimulation of the Central and Peripheral Nervous System COMPLETED

Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Stimwave Technologies Incorporated

K162161Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit K160600Freedom Spinal Cord Stimulator System K172644Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base K170141Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit K180981Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit

Related Devices (Code: GZB)

K162161Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger KitStimwave Technologies Incorporated K160600Freedom Spinal Cord Stimulator SystemStimwave Technologies Incorporated K172644Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading BaseStimwave Technologies Incorporated K170141Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger KitStimwave Technologies Incorporated K180981Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly KitStimwave Technologies Incorporated K191466SandShark Injectable Anchor (SIA) SystemStimwave Technologies, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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