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ProSomnus Sleep Technologies

United States·US-MF-000034424

Last updated September 17, 2026

About

Join thousands of users sleeping restfully without their CPAP. ProSomnus Therapy helps you get a restful night of sleep without noisy machines, masks, or hoses. Learn why hundreds of thousands of patients are ditching their CPAP and sleeping with ProSomnus.

From the manufacturer's own website. Source

What ProSomnus Sleep Technologies makes

ProSomnus Sleep Technologies makes mandible-repositioning sleep-disordered breathing orthosis devices, including the ProSomnus EVO Sleep and Snore Device and the ProSomnus IA MicrO2 with Patient Monitoring.

The company's portfolio includes devices classified as Class I and Class II, and is listed in registries such as eudamed and the FDA's 510k and UDI databases, with the company based in the US.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What type of devices does ProSomnus Sleep Technologies make?

ProSomnus Sleep Technologies makes mandible-repositioning sleep-disordered breathing orthosis devices, such as the ProSomnus EVO Sleep and Snore Device.

Where is ProSomnus Sleep Technologies based?

ProSomnus Sleep Technologies is based in the US.

Which registries list ProSomnus Sleep Technologies' devices?

ProSomnus Sleep Technologies' devices are listed in registries such as eudamed, and the FDA's 510k and UDI databases.

How are ProSomnus Sleep Technologies' devices classified?

ProSomnus Sleep Technologies' devices are classified as Class I and Class II.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: United States
Address: 5675, Gibraltar Drive, Pleasanton, United States
Website: prosomnus.com
LinkedIn: linkedin.com/company/prosomnus-sleep-technologies
Facebook: facebook.com/ProSomnusSleepTechnologies
Email: [email protected]
Phone: +1 8445375337
PRRC Contact: Divya Mavalli
EUDAMED SRN: US-MF-000034424
FDA FEI Number: 3013116677
DUNS Number: —

Catalogue (14)

Device	Model / Reference	Registries	Class	Status
ProSomnus EVO Sleep and Snore Device	EVO	EUDAMEDFDA UDI	Class II	Active
ProSomnus EVO [PH] Sleep and Snore Device	EVO [PH]	FDA UDI	Class II	Active
Prosomnus IA MicrO2 with Patient Monitoring	MicrO2 with Monitoring	FDA UDI	Class II	Active
ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring	EVO [PH] with Patient Monitoring	FDA UDI	Class II	Active
Prosomnus CA Sleep and Snore Device	CA	EUDAMEDFDA UDI	Class II	Active
ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring	K202529	FDA 510(k)	Class II	Active
ProSomnus RPMO2 OSA Device (RPMO2 OSA)	K252765	FDA 510(k)	Class II	Active
Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder	K172859	FDA 510(k)	Class II	Active
ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring	K221889	FDA 510(k)	Class II	Active
ProSomnus	MicrO2	EUDAMEDFDA UDI	Class I	Active
ProSomnus	[IA]	EUDAMEDFDA UDI	Class I	Active
ProSomnus	[IA] with PM	EUDAMEDFDA UDI	Class I	Active
ProSomnus	[CA] with PM	EUDAMEDFDA UDI	Class I	Active
ProSomnus	EVO with PM	EUDAMEDFDA UDI	Class I	Active

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