Device Category Dossier

Physiology/motion recording wristband

Device Category Dossier for Physiology/motion recording wristband. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Wearable multi-parameter monitors are reusable wrist-applied devices that incorporate single-lead electrocardiograph and reflectance photoplethysmograph technology , measuring and displaying electrocardiogram lead I whilst calculating heart rate and detecting atrial fibrillation or irregular heart rhythm . These devices supplement clinical screening for possible atrial fibrillation and are indicated for over-the-counter use in adults .