China-based Viatom Technologies won FDA 510(k) clearance for its Checkme Pro mult-diagnostic device, according to an FDA filing posted last week.
The ‘tricorder’ style device performs pulse oximetry, single-lead ECG recording, temperature measurement, sleep monitoring and movement sensing, according to the company’s site. The equipped ECG tracks heart rate, QRS duration, ST Segment and rhythm analysis.
The combo device can be set in either ‘home’ or ‘hospital’ mode, according to the company’s site. Home mode allows for daily spot checks using the device to record and log data from the ECG and Oximeter on a regular basis.
The device can also be placed on a patient’s arm to function as a continuous monitor and display ECG and SpO2. The European-cleared version of the device can also measure systolic blood pressure.
The device communicates with companion apps on smart-devices and can be used to transmit data to caretakers or physicians, the company said.
The 510(k) application, filed on April 1 this year, was cleared for use by the FDA on December 10, according to the filing.