NeuroMetrix, Inc. tells us it has received a U.S. FDA 510(k) clearance for an upgraded version of Quell, the company’s over-the-counter, 100% drug free chronic pain relief wearable. The new clearance means the device can be controlled directly via the Quell Relief smartphone app, thereby providing an unprecedented level of convenience and comfort when using Quell to treat chronic pain.
Background
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 via 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 January 6 – 9, at Sands Booth #73313. Furthermore the product is a finalist for the Last Gadget Standing award, which includes some of the most breakthrough products at CES.
Company comments
“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 and CEO NeuroMetrix. “It is a clear example of our unwavering 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.”
Source: Background
published: January 8, 2016 in: Approval/Clearance, News, Pain management