SleepioRx

Primary DI
00860008033024
Brand
SleepioRx
Company
Big Health Inc.
Model
v1
Device description
SleepioRx is a digital therapeutic intended for the treatment of chronic insomnia / insomnia disorder as an adjunct to usual care in patients aged 18 and older. SleepioRx is a prescription device delivering Cognitive Behavioral Therapy for Insomnia (CBT-I) and can be made available on the order of a licensed healthcare provider.
Published
2025-03-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K233577000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233577000Sleepio®Big Health, Inc.2024-08-05QVO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860008033024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008033024008600080330248600080330240860008033024

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

Contacts#

Phone, Email table
PhoneEmail
(707) 563-1049hello@bighealth.com

Regulatory Flags#

DUNS number
079826953
Device count
1

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15694311112112SomrystNox Medical ehf.QVO2024-12-30