Dreem 2
DREEM · Model EFM00MD · UDI-DI 00850010086019
10
510(k) clearances
59
Adverse events (1 deaths)
4
Recalls
108
Facilities
Description
Dreem 2 is a wireless sleep monitoring system consisting of a wearable headband that contains sensors to monitor sleep and a mobile application. Dreem 2 is intended to aid in relaxing and falling asleep and to generate reports, advices and contents to help the user better understand his or her sleep, and take steps to improve it.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-12-11 | RONAN MEDICAL LLC | Neurofeedback systems removed due to missing design and development documentation and devices may not perform as intended. |
| 2017-07-07 | Ondamed Inc | The firm was marketing the Ondamed System in the US without marketing clearance. As a corrective action, the firm revised its device design to comply with regulations. The firm has |
| 2015-10-01 | Powers Medical Devices, LLC | PAL unit has undergone significant technological changes since the previous 510(k) and labeling is not consistent with the cleared indications of the 510(k). |
| 2012-11-15 | EEG Info | EEG Info, Inc. is recalling the EEG Neuroamp device because they have identified a potential risk associated with the mislabeling of certain devices. |
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Get your free API keyRead the docsData 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.