Tentech obtains US FDA certification for high-frequency medical device ‘10THERMA’

Tentech obtains US FDA certification for high-frequency medical device ‘10THERMA’

Sales exceeded 500 units in just one year since its domestic debut in October last year. Taiwan's TFDA approved early this month... Forecast of a blast in the global medical device market

The U.S. Food and Drug Administration (FDA) granted medical device certification to Tentech's high-frequency medical device, '10THERMA'. Tentech (CEO Han Dong-ok) announced on the 21st that it has obtained FDA certification for TenTherma (US approved name '10THERMA').

10THERMA was first introduced in Korea in October 2022 and sold more than 500 units within a year of its launch. This month, it obtained certification from the Taiwan Food and Drug Administration (TFDA) and is gradually expanding its overseas certification. Thanks to this FDA approval, 10THERMA is scheduled to be sold in earnest starting next year.

Tentech is expected to stand out even more in the global medical device market by obtaining US FDA certification for 10THERMA. Han Dong-ok, CEO of Tentech, said, “10THERMA’s technology is recognized not only domestically but also overseas,” and added, “With this FDA approval, we have once again proven its safety and effectiveness.”

Meanwhile, 10THERMA has currently signed exclusive contracts in countries such as Taiwan, Hong Kong, Singapore, Malaysia, Indonesia, Vietnam, Thailand, Philippines, Russia, Uzbekistan, Kazakhstan, and Brazil.