Health-care firm NeuroMetrix has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its next-generation Quell device to treat chronic pain.
The upgraded over-the-counter and drug free chronic pain relief wearable device can be controlled directly through the Quell Relief smartphone app.
The company has developed Quell to treat patients with a wide range of chronic pain conditions.
NeuroMetrix president and CEO Dr Shai Gozani said: "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."
NeuroMetrix intends to make the device available for customers from March this year.
The company is showcasing Quell device at the CES in Las Vegas, US, which is being held from 6 to 9 this month.
Based in Waltham of Massachusetts, NeuroMetrix is involved in developing wearable medical technology and point-of-care tests to treat patients with chronic pain, nerve diseases and sleep disorders.