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Re: midtownmurphy post# 40333

Monday, 02/09/2015 3:51:15 PM

Monday, February 09, 2015 3:51:15 PM

Post# of 60230

LOL The FCC has APPROVED this as a TELECOMMUNICATIONS DEVICE. Stop ALREADY!!!



Yes the FCC has. That is not the issue. FCC is fairly easy to get and it only deals with the medical alert portion of the device. Vitall is marketing this as a medical monitoring device for doctors to monitor patents. That is where the FDA gets involved with the 510k process.

Vitall states this on its website.

Vitall™ is the most powerful and comprehensive patient-wearable healthcare monitoring device available. The system gives you a complete picture of your patient’s health. From their wrist to your dashboards, Vitall reports on activity, vital signs, medication consumption, and much more. The unprecedented combination of biometric sensors, wireless connectivity, 3D accelerometer and smartphone make it the most advanced healthcare “watch” available anywhere in the world.



Sense Vitall is marketing this as a medical monitoring device for patents it will need FDA approval for the blood pressure and glucose monitoring portion because they fall into the class II device

http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/ucm203018.htm

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