FDA.reportPublic FDA data

Somryst™

Primary DI
10851580008255
Brand
Somryst™
Company
PEAR THERAPEUTICS, INC.
Model
1
Device description
Somryst is a prescription-only digital therapeutic intended to provide a neurobehavioral intervention (Cognitive Behavioral Therapy for Insomnia - CBT-I) in patients 22 years of age and older with chronic insomnia. Somryst treats chronic insomnia by improving a patient's insomnia symptoms.Somryst uses sleep restriction and consolidation, limiting the time a patient spends in bed to match the amount of time they sleep. This treatment technique can increase risks to some patients whose pathophysiology may be worsened. Because of this, it is not appropriate for everyone.
Published
2020-09-09
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
PWEComputerized Behavioral Therapy Device For Psychiatric Disorders

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PWEComputerized Behavioral Therapy Device For Substance Use DisordersNeurology2

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
10851580008255PrimaryGS10
96439-0030-01SecondaryNDC/NHRIC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085158000825510851580008255

GMDN Terms#

Term, Definition table
TermDefinition
Cognitive therapy softwareA software program intended to be used with an off-the-shelf computer/tablet/smartphone to help improve a cognitive function (e.g., attention/concentration, memory, eye movement training to improve reading ability) by providing a patient with on-screen interactive sessions (e.g., text for audible reading, stimulating game-like activities); it is not intended for kinesiology-based neuromuscular rehabilitation. It may additionally be designed to screen for cognitive disorders, set baselines, and will typically show development (i.e., interactive). It is intended to be used at home, school, and in clinical settings.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079705123
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10851580008019reSET®1.4.62017-12-11
10851580008040reSET®1.42018-07-12
10851580008132reSET® Introductory Access Limited Version12019-08-25
10851580008149reSET® Introductory Access Limited Version (Mobile App, iOS)12019-08-25
10851580008156reSET® Introductory Access Limited Version (Mobile App, Android)12019-08-25
10851580008163reSET-O® Introductory Access Limited Version12019-08-25
10851580008170reSET-O® Introductory Access Limited Version (Mobile App, iOS)12019-08-25
10851580008187reSET-O® Introductory Access Limited Version (Mobile App, Android)12019-08-25
10851580008194reSET® Demo Version12019-11-25
10851580008200reSET® Demo Version (Mobile App, iOS)12019-11-25
10851580008217reSET® Demo Version (Mobile App, Android)12019-11-25
10851580008224reSET-O® Demo Version12019-11-25
10851580008231reSET-O® Demo Version (Mobile App, iOS)12019-11-25
10851580008248reSET-O® Demo Version (Mobile App, Android)12019-11-25
10851580008026reSET®1.5N/A2018-07-12
10851580008033reSET®1.5N/A2018-07-12
10851580008057reSET-O™1.1N/A2018-12-26
10851580008064reSET-O™1.1N/A2018-12-26
10851580008071reSET®12019-07-15
10851580008088reSET® Mobile App, iOS12019-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850074433002PursueCare RESETHarvest Bio LLCPWE2025-04-28
00850074433019PursueCare RESET-OHarvest Bio LLCPWE2025-04-28
00850074433026PursueCare RESET-OHarvest Bio LLCPWE2025-04-28
00850074433033PursueCare RESETHarvest Bio LLCPWE2025-04-28
10196439000005reSET®PEAR THERAPEUTICS, INC.PWE2022-06-08
10196439000012reSET® Non-Monetary CMPEAR THERAPEUTICS, INC.PWE2022-06-08
10196439000029reSET-O®PEAR THERAPEUTICS, INC.PWE2022-06-08
10196439000036reSET-O® Non-Monetary CMPEAR THERAPEUTICS, INC.PWE2022-06-08
10851580008194reSET® Demo VersionPEAR THERAPEUTICS, INC.PWE2019-11-25
10851580008200reSET® Demo Version (Mobile App, iOS)PEAR THERAPEUTICS, INC.PWE2019-11-25
10851580008217reSET® Demo Version (Mobile App, Android)PEAR THERAPEUTICS, INC.PWE2019-11-25
10851580008224reSET-O® Demo VersionPEAR THERAPEUTICS, INC.PWE2019-11-25
10851580008231reSET-O® Demo Version (Mobile App, iOS)PEAR THERAPEUTICS, INC.PWE2019-11-25
10851580008248reSET-O® Demo Version (Mobile App, Android)PEAR THERAPEUTICS, INC.PWE2019-11-25
10851580008132reSET® Introductory Access Limited VersionPEAR THERAPEUTICS, INC.PWE2019-08-25
10851580008149reSET® Introductory Access Limited Version (Mobile App, iOS)PEAR THERAPEUTICS, INC.PWE2019-08-25
10851580008156reSET® Introductory Access Limited Version (Mobile App, Android)PEAR THERAPEUTICS, INC.PWE2019-08-25
10851580008163reSET-O® Introductory Access Limited VersionPEAR THERAPEUTICS, INC.PWE2019-08-25
10851580008170reSET-O® Introductory Access Limited Version (Mobile App, iOS)PEAR THERAPEUTICS, INC.PWE2019-08-25
10851580008187reSET-O® Introductory Access Limited Version (Mobile App, Android)PEAR THERAPEUTICS, INC.PWE2019-08-25
10851580008071reSET®PEAR THERAPEUTICS, INC.PWE2019-07-15
10851580008088reSET® Mobile App, iOSPEAR THERAPEUTICS, INC.PWE2019-07-15
10851580008095reSET® Mobile App, AndroidPEAR THERAPEUTICS, INC.PWE2019-07-15
10851580008101reSET-O®PEAR THERAPEUTICS, INC.PWE2019-07-15
10851580008118reSET-O® Mobile App, iOSPEAR THERAPEUTICS, INC.PWE2019-07-15
10851580008125reSET-O® Mobile App, AndroidPEAR THERAPEUTICS, INC.PWE2019-07-15
10851580008057reSET-O™PEAR THERAPEUTICS, INC.PWE2018-12-26
10851580008064reSET-O™PEAR THERAPEUTICS, INC.PWE2018-12-26
10851580008040reSET®PEAR THERAPEUTICS, INC.PWE2018-07-12
10851580008026reSET®PEAR THERAPEUTICS, INC.PWE2018-07-12