--- title: Are VeRelief devices FDA Approved? description: VeRelief was designed, tested, and found compliant with FDA medical device quality standards, but because it does not treat an actual medical condition, it is not regulated by the FDA. VeRelief was fi --- [Skip to content](https://knowledge.hoolest.com/migration/knowledge/are-verelief-devices-fda-approved#main-content) English Show submenu for translations ![VeRelief-White.png\]](https://knowledge.hoolest.com/hs-fs/hubfs/VeRelief-White.png?height=40&name=VeRelief-White.png) Open main navigation Close main navigation - English Show submenu for translations - Go to hoolest.com Go to hoolest.com Hello. How Can We Help You? - There are no suggestions because the search field is empty. 1. [VeRelief Help Center](https://knowledge.hoolest.com/migration/knowledge?hsLang=en) 2. [Pre Purchase Support](https://knowledge.hoolest.com/migration/knowledge/pre-purchase-support?hsLang=en) 3. [Hoolest Product Information](https://knowledge.hoolest.com/migration/knowledge/pre-purchase-support?hsLang=en#hoolest-product-information) # Are VeRelief devices FDA Approved? VeRelief was designed, tested, and found compliant with FDA medical device quality standards, but because it does not treat an actual medical condition, it is not regulated by the FDA. VeRelief was first developed in 2018 as part of Dr. Nicholas Hool's Ph.D. program in biomedical engineering. For 4 years, Dr. Hool and his team of engineers created prototypes, conducted pilot safety studies, worked with medical device consultants and design firms, developed a quality management system to ensure top product quality, conducted a national clinical trial, and actually submitted an FDA clearance application. VeRelief was found to comply with every FDA quality regulation, but since it does not claim to treat any medical condition, it does not fall under FDA regulatory approval.    The VeRelief device is classified as a general wellness product, designed to promote relaxation and stress relief through vagus nerve stimulation. We have taken great care to ensure the safety and effectiveness of our device, and we have conducted extensive testing and research to validate its benefits. Our customers can rest assured that they are using a safe and reliable product that can help them manage their stress and anxiety in a natural and non-invasive way. VeRelief is used by top wellness doctors in functional neurology, psychiatry, trauma therapy, sports medicine, functional medicine, and many other clinical fields.    - [General Information](https://knowledge.hoolest.com/migration/knowledge/general-information?hsLang=en#main-content) - [General Company Information](https://knowledge.hoolest.com/migration/knowledge/general-information?hsLang=en#general-company-information) - [The Science Behind VeRelief](https://knowledge.hoolest.com/migration/knowledge/general-information?hsLang=en#the-science-behind-verelief) - [Pre Purchase Support](https://knowledge.hoolest.com/migration/knowledge/pre-purchase-support?hsLang=en#main-content) - [Precaution & Safety](https://knowledge.hoolest.com/migration/knowledge/pre-purchase-support?hsLang=en#precaution-safety) - [Hoolest Product Information](https://knowledge.hoolest.com/migration/knowledge/pre-purchase-support?hsLang=en#hoolest-product-information) - [Use Case/Application Information](https://knowledge.hoolest.com/migration/knowledge/pre-purchase-support?hsLang=en#use-case-application-information) - [Product Comparison](https://knowledge.hoolest.com/migration/knowledge/pre-purchase-support?hsLang=en#product-comparison) - [Policy Questions](https://knowledge.hoolest.com/migration/knowledge/pre-purchase-support?hsLang=en#policy-questions) - [Checkout Information](https://knowledge.hoolest.com/migration/knowledge/pre-purchase-support?hsLang=en#checkout-information) - [Shipping Protection](https://knowledge.hoolest.com/migration/knowledge/pre-purchase-support?hsLang=en#shipping-protection) - [Fulfillment Information](https://knowledge.hoolest.com/migration/knowledge/pre-purchase-support?hsLang=en#fulfillment-information) - [Unit/Reoccurring Costs](https://knowledge.hoolest.com/migration/knowledge/pre-purchase-support?hsLang=en#unit-reoccurring-costs) - [Discounts & Promotions](https://knowledge.hoolest.com/migration/knowledge/pre-purchase-support?hsLang=en#discounts-promotions) - [Post Purchase Support](https://knowledge.hoolest.com/migration/knowledge/post-purchase-support?hsLang=en#main-content) - [General Questions](https://knowledge.hoolest.com/migration/knowledge/post-purchase-support?hsLang=en#general-questions) - [Policy Questions](https://knowledge.hoolest.com/migration/knowledge/post-purchase-support?hsLang=en#policy-questions) - [Shipping & Fulfillment Questions](https://knowledge.hoolest.com/migration/knowledge/post-purchase-support?hsLang=en#shipping-fulfillment-questions) - [Using Package Protection](https://knowledge.hoolest.com/migration/knowledge/post-purchase-support?hsLang=en#using-package-protection) - [User Experience Questions](https://knowledge.hoolest.com/migration/knowledge/post-purchase-support?hsLang=en#user-experience-questions) - [Getting Started & Using VeRelief](https://knowledge.hoolest.com/migration/knowledge/post-purchase-support?hsLang=en#getting-started-using-verelief) - [Comparison Information](https://knowledge.hoolest.com/migration/knowledge/post-purchase-support?hsLang=en#comparison-information) - [Protocols for Use](https://knowledge.hoolest.com/migration/knowledge/post-purchase-support?hsLang=en#protocols-for-use) - [Unit Maintenance Questions](https://knowledge.hoolest.com/migration/knowledge/post-purchase-support?hsLang=en#unit-maintenance-questions) - [Device Troubleshooting & Technical Issues](https://knowledge.hoolest.com/migration/knowledge/post-purchase-support?hsLang=en#device-troubleshooting-technical-issues) [![](https://knowledge.hoolest.com/hs-fs/hubfs/Hoolest%20Logo_Vertical.png?width=497&height=351&name=Hoolest%20Logo_Vertical.png)](https://knowledge.hoolest.com/?hsLang=en) Copyright © 2026, Hoolest Performance Technologies