FDA.reportPublic FDA data

ProSomnus Charging Station

Primary DI
00850022853050
Brand
ProSomnus Charging Station
Company
PROSOMNUS SLEEP TECHNOLOGIES
Model
Charging Station
Device description
The ProSomnus Charging Station is used to charge the HWO2/RPMO2 devices.
Published
2026-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850022853050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850022853050008500228530508500228530500850022853050

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive device battery charger/transceiver/cableAn electrically-powered device designed to supply an electrical charge to the battery of a noninvasive device to recharge it for operation, and to both receive data from and transmit data to noninvasive devices via a direct/wired or wireless connection. It is typically in the form of an electronic circuitry housing with a cable.

Regulatory Flags#

DUNS number
075438768
Device count
1
Premarket exempt
true
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850022853036ProSomnus RPMO2 OSA DeviceRPMO2 OSA2026-04-24
00850022853067ProSomnus HWO2 DeviceHWO22026-04-24
00850022853012ProSomnus EVO [PH] Sleep and Snore DeviceEVO [PH]2024-03-29
00850022853029ProSomnus EVO [PH] Sleep and Snore Device with Patient MonitoringEVO [PH] with Patient Monitoring 2024-03-29
00863039000485ProSomnus EVO Sleep and Snore DeviceEVO2024-03-29
00863039000492ProSomnus EVO Sleep and Snore Device with Patient MonitoringEVO with Patient Monitoring 2024-03-29
00863039000409Prosomnus CA Sleep and Snore DeviceCA 2017-12-06
00863039000416Prosomnus IA MonogramIA Monogram2017-06-21
00863039000423Prosomnus IA MicrO2MicrO22017-06-21
00863039000430Prosomnus IA with Patient MonitoringIA Monogram Monitor2017-06-21
00863039000454Prosomnus CA Sleep and Snore Device with Patient MonitoringCA Monitor2017-12-06
00863039000447Prosomnus IA MicrO2 with Patient MonitoringMicrO2 with Monitoring2017-06-21