Ybrain’s migraine relief device wins US FDA clearance

Ybrain, a Korean electroceuticals maker, said its migraine relief device, Doopang, has received 510(k) clearance from the U.S. FDA. The 510(k) process is a regulatory pathway used by the FDA to ensure the safety and effectiveness of medical devices.

Doopang works by delivering transcutaneous electrical nerve stimulation (TENS) to the trigeminal nerve area on the forehead, which helps to calm overactive nerves and alleviate migraine symptoms.

Doopang is the first locally-developed migraine relief device to receive approval from the Ministry of Food and Drug Safety in 2020. In Korea, the device is available without a prescription and can be purchased at select national pharmacy chains or Ybrain’s online shop. 

The device features two primary modes -- a preventive mode and an acute mode. The preventive mode is designed for use before significant events, such as exams or interviews, to help reduce stress, while the acute mode is intended for immediate use when a migraine or its early symptoms occur.

To use Doopang, patients attach a patch above their eyebrows and place the coin-sized device on the patch. The preventive mode requires 20 minutes of use, whereas the acute mode requires about 60 minutes.

Clinical results have shown that regular use can also decrease the frequency of migraines.

“This FDA approval certifies the safety and efficacy of our device is on an international level,” Ybrain CEO Lee Ki-won said. “We are also hopeful that our other products, such as the prescription depression electronic medication MINDD STIM and the quantitative EEG diagnostic device MINDD SCAN, will achieve similar success with the FDA.”