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NightWare

Nightware Incorporated · Model 100001 · UDI-DI 00860005400706

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510(k) clearances

Adverse events

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Description

The NightWare device includes a software application and the NightWare server. The device uses an Apple Watch® and an Apple iPhone® for its platform. These components monitor your sleep behavior and, using a proprietary formula, creates a unique sleep profile to help you get a better night’s sleep. NightWare is designed to monitor your heart rate and movement throughout the night and occasionally provide vibrotactile interventions (haptic feedback) through the Apple Watch while you are sleeping. These interventions will occur when NightWare detects that you have exceeded a certain threshold and will disrupt the phenomena consistent with a nightmare at the time that it is occurring. The first night you use NightWare, the watch will not provide any of these interventions because it is gathering enough data to create your unique sleep profile. The data that NightWare collects from the Apple Watch includes: Heart Rate, Body Movement (Acceleration),Body Position (Rotation). This information is securely sent to the NightWare servers and processed to help you improve the quality of your sleep.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.