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510(k) Data Aggregation
K Number
K201456Device Name
Scan Monitor
Manufacturer
Withings SA
Date Cleared
2021-10-05
(491 days)
Product Code
DPS, DQA, DXH
Regulation Number
870.2340Why did this record match?
Applicant Name (Manufacturer) :
Withings SA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Scan Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The Scan Monitor also displays ECG rhythms and detects the presence of atrial fibrillation (when the monitor is prescribed or used under the care of a physician). The Scan Monitor is intended for use by healthcare professionals, patients with known or suspected heart conditions and health-conscious individuals.
The Scan Monitor is also indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2). The Scan Monitor is intended for spot-checking of adult patients in hospitals, clinics, long-term care facilities, and homes.
Device Description
The Scan Monitor is a wearable, Bluetooth-connected wrist-worn watch that records two medical measurements-heart activity (electrocardiogram (ECG)) and oxygen saturation (SpO2)-as well as other measurements including step cycles, running, biking, and walking. The Scan Monitor has a companion mobile application called Health Mate. The Scan Monitor is available in two sizes, 38 mm and 42 mm, which have different watch faces but are otherwise identical.
The Scan Monitor has two stainless steel electrodes integrated on the back case of the watch and are always in contact with the skin. One of these two electrodes is used to obtain a reference signal and reduce the noise on the ECG signal. A third electrode is accessible by the free hand (the hand that does not wear the device) on the top of the device.
The Scan Monitor classifies ECG signals as follows:
- 0 Normal Sinus Rhythm;
- Atrial Fibrillation; .
- . Inconclusive;
- 0 Noisy.
The SpO2 measurements are obtained by a photoplethysmograph sensor located at the backcase of the product. This sensor is composed of three LEDs (green, red, and infrared) and two photodiodes (one large band and one with a green filter). The Scan Monitor is validated for an SpO2 range of 70% to 100% and an SpO2 range between 85% to 100% is displayed on the gauge.
All measurements obtained by the Scan Monitor are available in the companion Health Mate app.
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