Device Dossier

Physiology/motion recording wristband

Device Dossier for Physiology/motion recording wristband (Physiology/motion recording wristband, Class IIa, sponsor Masimo). ARTG record, intended…

Intended purpose

Masimo W1™ is intended to be worn on the wrist for the spot-checking of ECG and other continuous parameters (e.g., pulse oximetry). The watch is intended to be used in hospital, hospital-type facilities, long-term care facilities, and home. Indicated for patients with suspected heart conditions and health-conscious individuals, for the detection, display, recording, and transferring of a single lead ECG and determination of ECG parameters (e.g., Heart Rate, Atrial fibrillation) on adults.

TGA Public Summary