AFrame Digital's mobile monitor cleared as Class II device

AFrame Digital has received FDA 510(k) clearance to market its flagship MobileCare Monitor system as a Class II device. Since 2009, MobileCare Monitor has been cleared as a Class I device.

The MobileCare Monitor service offers a hosted platform for care professionals to support patients across the continuum of care. Someone wearing AFrame’s wireless, wristwatch-based health monitor can press a button to request help or the system will generate alerts when there are vital sign readings outside personal baseline or target ranges.

MobileCare Monitor's patented method for non-intrusively and continuously gathering data about a person’s activity is combined with vital sign and gait data to create individualized baselines of wellness. Vital sign data is obtained wirelessly from Class II FDA-cleared devices such as Bluetooth-enabled glucometers, pulse oximeters, weight scales and blood pressure cuffs.