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ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring

FDA UDI

Class II (US FDA UDI)

by ProSomnus Sleep Technologies

Identity

Trade Name
ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring FDA UDI
Generic Name
Mandible-repositioning sleep-disordered breathing orthosis FDA UDI
Model / Reference
EVO [PH] with Patient Monitoring FDA UDI

Identifiers

Primary DI / UDI-DI
00850022853029 FDA UDI
510(k) Number
K221889 FDA UDI
FDA Product Code
LRK FDA UDI
LQZ FDA UDI
GMDN Term
Mandible-repositioning sleep-disordered breathing orthosis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.5570 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Mandible-repositioning sleep-disordered breathing orthosis

ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring by ProSomnus Sleep Technologies — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Mandible-repositioning sleep-disordered breathing orthosis.

Cleared under the same submission

K221889 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
ProSomnus Sleep Technologies

Sources (1)

  • FDA UDI 646e0256-73d7-42f9-b3b4-f08d68bb2850 33 fields · synced Jun 8, 2026