General Sleep

General Sleep specializes in two primary categories of devices: electroencephalographic (EEG) monitoring systems and home-use sleep apnoea recording systems. These products are designed for collecting and analyzing sleep data outside of clinical settings, such as in patients' homes. The most notable example is the Zmachine, which falls under these categories.

General Sleep is based in the United States. Since it operates within the US market, its devices are subject to regulation by the US Food and Drug Administration (FDA). The company’s products are classified as Class II medical devices, which means they undergo specific regulatory controls to ensure safety and effectiveness before being listed in the FDA’s Unique Device Identifier (UDI) database.

General Sleep’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices commercially distributed in the United States, ensuring transparency and traceability for regulatory and market surveillance purposes.

General Sleep’s devices are classified as Class II medical devices. This classification indicates they pose moderate risk and require special controls beyond general controls to ensure their safety and performance. Class II devices are regulated by the FDA to mitigate risks associated with their use, such as those related to sleep apnoea monitoring or EEG data collection in non-clinical environments.