Received a Galaxy Watch as a Chuseok Gift, but Use Prohibited for Under 22s and Pregnant Women [Why&Next]

Key Health Features Restricted to Users Aged 22 and Older

Sleep Apnea Detection Unavailable During Pregnancy

Aligned with US FDA Clinical Age Standards

Kim Suhyeong, who lives in Mokdong, Seoul, bought Samsung Electronics’ Galaxy Watch9 as a gift for his son in celebration of Chuseok. His 17-year-old son loves running and often rides his bicycle, so Kim thought the various health features built into the smartwatch would make it more suitable for daily wear than a regular watch. While reading the manual for more details, Kim came across an unexpected note: although the Galaxy Watch9 is equipped with useful health monitoring functions, such as the ability to detect signs of sleep apnea, the guide stated that “users must be age 22 or older.” When a user under 22 attempts to use these functions, restrictions and warning messages appear. Since Kim often sees teenagers using smartwatches instead of smartphones, he became curious about the age restriction and even felt a bit uneasy, wondering whether there could be safety concerns if an adolescent were to use the device.

The reason for restricting Galaxy Watch9 use for those under age 22 is due to the clinical trial and performance validation standards. When these features were developed as Software as a Medical Device (SaMD), clinical trials and performance evaluations were conducted only with adult participants aged 22 and over. Because there is insufficient clinical data for users under 22, and the accuracy of results cannot be officially guaranteed, these functions are restricted for this age group.

A Samsung Electronics official explained, “The applications for measuring blood pressure and electrocardiogram (ECG) on Samsung Health Monitor must be approved by regulatory agencies such as the U.S. Food and Drug Administration (FDA), and the clinical test subjects required for approval must be adults aged 22 and over. The FDA’s medical device standards and corresponding clinical trial protocols specify this age, which is aligned with global standards,” he added.

The FDA and other global health authorities have set the minimum clinical trial age for over-the-counter (OTC) medical apps at 22 when approving their safety and efficacy. Also, since the algorithms and sensor measurement values are designed based on adults, there could be inaccuracies for minors, so for safety reasons, minors are excluded from using these functions.

Various health features equipped in the Galaxy Watch9. Photo by Sojeong Seo.

Particularly, conditions such as atrial fibrillation and sleep apnea—detectable by Galaxy Watch—occur most frequently in adults and those in high-risk age groups. In 2023, Samsung Electronics received FDA and Korean Ministry of Food and Drug Safety approval for its irregular heart rhythm notification feature, which alerts users to potential atrial fibrillation. However, the sleep apnea detection function on Galaxy Watch9 is only available in some countries, and there are specific warnings advising against the use of this feature for pregnant women and for anyone previously diagnosed with sleep apnea.

A representative of the Ministry of Food and Drug Safety stated, “Samsung Electronics included the restriction on users under 22 in the user precautions to obtain domestic approval for the device,” and added, “Samsung is not currently pursuing any process to lower the eligible age for users.”

Some believe stronger warnings should be issued for pregnant women. Park Jiyeon, a pregnant woman in her 30s, said, “I had no idea Galaxy Watch9 had restrictions for pregnant users. Even if it’s harmless to the body, it could still have some impact—so clearer guidance would be a good idea.” A Samsung Electronics official explained, “When measuring body composition, a tiny electrical current passes from the user’s finger to the watch and through the body. This current is at a level harmless to humans, but because even minimal risks can affect pregnant women, we recommend against using these measurements as a precaution.”

This content was produced with the assistance of AI translation services.