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FDA 510(k)

Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit

K-Number: K180981 · 2018-09-19

ApplicantStimwave Technologies Incorporated
Decision Date2018-09-19
Product CodeGZB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit is a medical device manufactured by Stimwave Technologies Incorporated. It received FDA 510(k) clearance on 2018-09-19 under approval number K180981. 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 Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit?

Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit is a medical device that received FDA 510(k) clearance on 2018-09-19. It is manufactured by Stimwave Technologies Incorporated. The 510(k) number is K180981.

When was Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit approved by the FDA?

Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit received FDA 510(k) clearance on 2018-09-19, under approval number K180981.

What company makes Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit?

Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit is manufactured by Stimwave Technologies Incorporated.

What is the FDA product code for Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit?

The FDA product code for Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit is GZB.

Related Clinical Trials

NCT07517172 Evaluating Noninvasive Brain Stimulation for TMD Pain: A Feasibility Study RECRUITING NCT07614568 Evaluating the Efficacy and Safety of Octane Aether for Treating Chronic Low Back Pain NOT_YET_RECRUITING NCT07612085 A Wearable Biosensor Patch for Non-Invasive Monitoring for Patients Undergoing Abdominal or Chest Surgery NOT_YET_RECRUITING NCT07187388 Investigating the Impact of Electrical Stimulation on Facial Pain, Jaw Movement and Oral Health in People With Motor Neuron Disease. RECRUITING NCT07591935 AI and Mindfulness Meditation for Stress Reduction in Medical Students COMPLETED NCT07095920 RESPARK - Brain Q for Chronic Stroke RECRUITING

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 K182720Freedom Spinal Cord Stimulator (SCS) System

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 K191466SandShark Injectable Anchor (SIA) SystemStimwave Technologies, Inc. K190960Nalu Lead Blank (50cm)Boston Scientific Neuromodulation

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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