DyAnsys’ First Relief Device Gets 510(k) Clearance

DyAnsys has received the FDA’s 510(k) clearance for First Relief, its wearable electrical neurostimulation device for symptomatic relief of chronic, intractable pain from diabetic peripheral neuropathy.

Placed on the ear, the device administers continuous pulses of a low-level electrical current, providing multiple treatments for up to 56 days.

The clearance was based on a study that showed the device significantly reduced pain intensity as well as enhancing sleep and mood.

The device “offers a significant treatment option without drugs or narcotics," the company said.