The Withings Scan Monitor 2.0 is a smart scale with a retractable handle that records, stores, and transfers lead II and lead III of a two-channel electrocardiogram (ECG). It also calculates and displays leads I, aVR, aVF, and aVL, as well as detects the presence of atrial fibrillation. The device is intended for use by healthcare professionals, patients with known or suspected heart conditions, and health-conscious individuals.
Indications for Use
The Withings Scan Monitor 2.0 is intended to record, store, and transfer lead II and lead III of a two-channel electrocardiogram (ECG). It also calculates and displays leads I, aVR, aVF, and aVL. The device is intended for adult patients in hospitals, clinics, long-term care facilities, and homes.
Comparison to Predicate Device
The Withings Scan Monitor 2.0 is substantially equivalent to the predicate device, Scan Monitor. The only minor difference is that the subject device records lead II and lead III of a two-channel electrocardiogram (ECG) and calculates lead I, whereas the predicate device analyzes a single-channel ECG and displays only lead I. Both devices use ECG leads for rhythm classification assessment.
Manual:
Download: 510(k) Premarket Notification Database for the Withings Scan Monitor 2.0
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