VivaLnk, a digital medical company founded by Chinese in Silicon Valley, recently received a notice from the US Food and Drug Administration (FDA) that the company's product "FeverScout" (Child Intelligence Thermometer) has passed the US FDA's 510(k) certification. "K162137". After the FDA certification, VivaLnk is qualified to sell FeverScout in the US market, which will have a positive impact on expanding the US market, and will further broaden the sales area of ​​the product in the international market.
FeverScout is a small patch made of flexible silicone and polyurethane containing VivaLnkeSkin. VivaLnkeSkin is a soft film embedded in a planar microsensor that monitors body temperature. The FeverScout patch has only half the size of the palm. When used, it is attached to the child's armpit. After pairing with the mobile phone via Bluetooth, it can achieve near-distance 24-hour uninterrupted body temperature tracking to the nearest 0.1 degree. When the body temperature is outside the normal range, it can also be alarmed by mobile phone. It is very convenient for parents who need to repeatedly measure body temperature when the child has a fever or who can't take care of the child from time to time. The app also keeps track of body temperature for a long time, allowing the user to record the food they have eaten, the dose of medication they have taken, etc., all without having to wake up the child or put something in their mouth.
Wearable devices are increasingly infiltrating into our lives, and many people nowadays like to wear smart watches and live healthier, but there is a limit between casual wearables and formal medical devices . The release of the former does not require supervision, while the latter needs to comply with US Food and Drug Administration (FDA) regulations. The US FDA has incorporated medical wearable devices and apps into medical device management, and it needs to pass the technology and effectiveness test before it can be listed. The threshold is to curb the disorderly competition in the market; the second is to protect the safety and health of patients; It is confirmed the efficacy. The FDA has always been regarded as the benchmark for food and drug safety regulation, and has set a benchmark for food and drug regulation worldwide with its rigorous, strict and strict style. FeverScout is FDA-approved, which shows the quality of this product.
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