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 the device name listed in this FDA 510(k) record. The listed applicant is Stimwave Technologies Incorporated. It received FDA 510(k) clearance on 2019-03-29 under 510(k) 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. The listed applicant is Stimwave Technologies Incorporated. The 510(k) number is K182720.

When did Freedom Spinal Cord Stimulator (SCS) System receive FDA 510(k) clearance?

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

Who is the listed applicant for Freedom Spinal Cord Stimulator (SCS) System?

The FDA 510(k) record lists Stimwave Technologies Incorporated as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04618471Paresthesia-Free Fast-Acting Subperception (FAST) StudyACTIVE_NOT_RECRUITING NCT04662905Novel Treatment Delivery of ECAP-controlled Closed-loop SCS for Chronic PainRECRUITING NCT06647576Exploring Neurosphere's Remote Monitoring and Virtual Clinic Features in Improve Quality of Life and Reduce CostsCOMPLETED NCT07698496Evaluation of the Feasibility and Efficacy of a Chronic Brain-computer Interface for Speech Rehabilitation in Patients With Locked-in-syndrome (LIS)NOT_YET_RECRUITING NCT03228420Comparison of 10 kHz SCS Combined With CMM to CMM Alone in the Treatment of Neuropathic Limb PainCOMPLETED NCT04326192Brown Adipose Tissue Activation by Spinal Cord StimulationRECRUITING

Other records listing Stimwave Technologies Incorporated as applicant

K191466SandShark Injectable Anchor (SIA) System K180981Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit 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 K162161Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit K160600Freedom Spinal Cord Stimulator System

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Related Devices (Code: GZB)

K233801Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve StimulationBoston Scientific Neuromodulation K221376Nalu Neurostimulation SystemBoston Scientific Neuromodulation K203547Nalu Neurostimulation SystemBoston Scientific Neuromodulation K202274Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kitsBoston Scientific Neuromodulation K201618Nalu Neurostimulation SCS systemBoston Scientific Neuromodulation K191466SandShark Injectable Anchor (SIA) SystemStimwave Technologies, Inc.

Official Source

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