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FDA 510(k)

Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit

K-Number: K162161 · 2016-12-16

ApplicantStimwave Technologies Incorporated
Decision Date2016-12-16
Product CodeGZB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit is a medical device manufactured by Stimwave Technologies Incorporated. It received FDA 510(k) clearance on 2016-12-16 under approval number K162161. 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 Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit?

Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit is a medical device that received FDA 510(k) clearance on 2016-12-16. It is manufactured by Stimwave Technologies Incorporated. The 510(k) number is K162161.

When was Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit approved by the FDA?

Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit received FDA 510(k) clearance on 2016-12-16, under approval number K162161.

What company makes Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit?

Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit is manufactured by Stimwave Technologies Incorporated.

What is the FDA product code for Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit?

The FDA product code for Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit is GZB.

Related Clinical Trials

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Related PubMed Literature

PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025)

Other Devices by Stimwave Technologies Incorporated

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 K182720Freedom Spinal Cord Stimulator (SCS) System

Related Devices (Code: GZB)

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. 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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