[News Space=Reporter seungwon lee] Ceragem (CEO Lee Kyung-soo) announced on the 10th that its 'Master V7' has received approval from the U.S. Food and Drug Administration (FDA). Ceragem is expected to use this as a stepping stone to further strengthen its position in the global medical device market.

Ceragem has obtained approval from the U.S. Food and Drug Administration for a total of four indications for 'Master V7', the representative product of the Master series: △improved blood circulation, △relief of muscle pain, △relief of joint pain, and △muscle relaxation. V7 has an added 'cervical (neck) mode' that includes massage patterns specialized for the neck and shoulders, such as tilting massage, to allow for more intensive management of stiff neck and shoulder areas. It is equipped with a sophisticated spine scan function that calculates the length and curvature of the spine, and the internal heating ceramic material exerts concentrated heat of up to 65 degrees to press key areas and relieve stiff muscles.

Prior to this, Ceragem Master V7 was certified by the Korea Food and Drug Administration (Ministry of Food and Drug Safety) for a total of five uses: △ helping treat herniated intervertebral discs, △ helping treat degenerative stenosis, △ relieving muscle pain, △ improving blood circulation, and △ helping treat menstrual pain.

Ceragem, which has successfully entered the global market with various healthcare products, has secured an even stronger growth momentum by internationally proving its efficacy and effectiveness as a medical device through this approval.

A Ceragem official said, “This FDA approval is another validation of Ceragem’s outstanding R&D capabilities and stability,” and “This will be an important milestone in establishing our position as a global home healthcare company in the future.”

Meanwhile, Ceragem participated in CES 2025 held in Las Vegas on the 7th and presented its vision of 'Future Homes for Healthy Living'. During the exhibition period, it had active discussions on technology collaboration and sales with about 50 companies including domestic university hospitals, home appliance companies, and companies from the US, Canada, the UK, China, and Australia. At the site, various exhibition products such as Ceragem's spinal management medical devices and massage chairs, as well as Celtron and Balance AI Medi Water, attracted attention.