The American Food and Drug Administration warns .. The feature of measuring blood pressure in “WOP” illegal and the company responds technology

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The US Food and Drug Administration issued a warning of the pressure measurement advantage provided by the health bracelets.View“(WhOP) recently in its products, because it did not get the necessary licenses to be classified as medical devices, according to a report published by the” Life Hacker “technical website.

The company “Wube” is one of the leading companies in the wearable healthy bracelet industry, which comes with a unique design that does not include a screen to display data, as it depends mainly on data collection and display through the application on the phone.

The feature of measuring its blood pressure and its analyzes was part of the company’s announcement of new products and benefits last May, and the company says that the feature of measuring its blood pressure and its analyzes is used to measure the performance of athletes and provide tips that help improve sports performance.

The American Food and Food Authority warned in the form of a letter published on the official’s website, in which it clarified that this feature is redressing the “WOP” devices to become clear medical devices, which is subject to the regulatory laws of medical devices because of its direct impact on the user’s life, according to a report published by the CNBC website.

Stuttgart, Germany - 06-01-2024: Person holding smartphone with logo of US wearable technology company WHOOP Inc. in front of website. Focus on phone display. Unmodified photo.
The Wube System provides one estimated reading daily to measure blood pressure, based on a single medium reading (Stradoc)

The authority added that “Wube” makes itself vulnerable to taking strict legal measures against it, such as reservations and civil financial penalties in the event that it fails to address the violations indicated by the agency, stressing that the company has 15 working days to respond to these demands.

For its part, “WOP” explained by the company’s official spokesman in the “CNBC” report that the company’s system provides one estimated range daily with only one medium reading, and this makes it directly different from the traditional blood pressure measuring devices used in the diagnosis of the disease.

The company also requires the user to add 3 hand pressure readings in order to use this feature and make it available, and the spokesperson added that blood pressure measuring data is not different from the rest of the data provided by the company, such as the heart rate and the rate of breathing, as it is one of the measurements that have medical uses to diagnose diseases.

“We believe that the agency exceeds its authority in this case by trying to regulate the non -medical well -being as a medical device,” the company spokesman told CNBC. The report also stated that the WPB company previously obtained the license of the Food and Drug Authority to use the electrical cardiac planning feature.

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