FDA.reportPublic FDA data

Somryst

Primary DI
15694311112112
Brand
Somryst
Company
Nox Medical ehf.
Model
SOMRYST
Catalog number
651010
Published
2024-12-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QVOComputerized Behavioral Therapy Device For Insomnia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QVOComputerized Behavioral Therapy Device For InsomniaNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191716000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191716000SomrystPear Therapeutics, Inc.2020-03-23QVO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15694311112112PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1569431111211215694311112112

GMDN Terms#

Term, Definition table
TermDefinition
Mental health/function therapeutic software, screen-viewedA screen-based (non-virtual-reality) software program intended to be used with an off-the-shelf computer/smart device to help improve mental health/wellbeing (e.g., control effects of mood disorders, stress) and/or a cognitive function (e.g., concentration, memory, eye movement training to improve reading) by providing a patient with on-screen interactive sessions. It may additionally be designed to assess cognition/mental health, set baselines, help manage pain, and will typically indicate development (i.e., interactive). It is not intended for kinesiology-based neuromuscular rehabilitation. It is intended to be used by the patient which may involve clinical assistance/recommendations.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
365741462
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15694311111887Nox Nasal Pressure Cannula with FilterNOX-MDR_CANAF405520112026-01-28
15694311111894Nox Nasal Pressure Cannula with FilterNOX-MDR_CANAF405520112026-01-28
15694311111672Nox SAS Body Cable - RightESNAP4SASRMPAC1US5622162025-06-06
15694311111689Nox SAS Body Cable - LeftESNAP4SASLMPAC1US5622172025-06-06
15694311111719Nox SAS Head CableESNAP10SASLMPAC1US5622182025-06-06
15694311111191Nox SAS Body Cable - RightESNAP4SASRMPAC1US5622162025-06-06
15694311111207Nox SAS Body Cable - LeftESNAP4SASLMPAC1US5622172025-06-06
15694311111214Nox SAS Head CableESNAP10SASLMPAC1US5622182025-06-06
15694311112099DeepRESPDEEPRESP2025-06-06
15694311112075Noxturnal WebNOXTURNAL_WEB2025-06-05
15694311110477Nox Mini USB CableNOX-USBCPAC15620112016-09-16
15694311110736QDC-PRO KitNOX-QDCPETL_KIT15140112016-09-16
15694311110354Nox Snap-on Lead, 100 cmNOX-ESNAP11PAC25540282016-09-16
15694311110361Nox Snap-on Double Lead, 50/100 cmNOX-ESNAP1PAC15543102016-09-16
15694311110378Nox Snap-on Double Lead, 30/50 cmNOX-PESNAP1PAC15543112016-09-16
15694311110279Nox Snap-on Lead, 50 cmNOX-ESNAP7PAC25540202016-09-16
15694311110286Nox Snap-on Lead, 30 cmNOX-PESNAP7PAC25540212016-09-16
15694311110316Nox Snap-on Lead, 150 cmNOX-ESNAP9PAC25540242016-09-16
15694311110323Nox Snap-on Lead, 100 cmNOX-PESNAP9PAC25540252016-09-16
15694311110330Nox Snap-on Lead, 150 cmNOX-ESNAP10PAC25540262016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860008033024SleepioRxBig Health Inc.QVO2025-03-14