NeuroMetrix Announces FDA 510(k) Clearance of Wearable Pain Relief Technology (with video)

NeuroMetrix Inc. kicked off CES 2016 in a big way, announcing it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for an upgraded version of Quell, the company’s over-the-counter, 100 percent drug-free chronic pain relief wearable.

Under this 510(k), the Quell device can be controlled directly via the Quell Relief smartphone app. This provides an unprecedented level of convenience and comfort when using Quell to treat chronic pain, company executives claim.

“This 510(k) further advances Quell technology by allowing the device to be conveniently and safely controlled via a smartphone,” said Shai Gozani, M.D., Ph.D., president/CEO of NeuroMetrix. “It is a clear example of our commitment to creating the most clinically effective and technologically innovative wearable therapeutic solution for people suffering from chronic pain. It is only fitting that we are making this announcement at CES 2016 which is the international showcase for consumer technology breakthroughs.”

Quell is designed for people with a wide range of chronic pain conditions. The latest version of Quell gives users the option to control their therapy through a mobile app and includes several additional enhancements including extended battery life and advanced sleep tracking. It will be available in March 2016. NeuroMetrix will have a free upgrade program for existing Quell users who send in their previous generation devices when the new version is available in March.

NeuroMetrix is exhibiting Quell at the CES in Las Vegas from Jan. 6 – 9. Quell is a finalist for the Last Gadget Standing award, which includes some of the most breakthrough products at CES.

NeuroMetrix develops wearable medical technology and point-of-care tests that help patients and physicians better manage chronic pain, nerve diseases, and sleep disorders. The company is based in Waltham, Mass., and was founded as a spinoff from the Harvard-MIT Division of Health Sciences and Technology in 1996.

Watch the video below to learn more about Quell: