AspyreRx

Primary DI
00860011146704
Brand
AspyreRx
Company
Better Therapeutics, Inc.
Model
ma.1.0.0
Device description
BT-001 (AspyreRx) is a prescription-only digital therapeutic device intended to provide cognitive behavioral therapy to treat patients 18 years or older with type 2 diabetes.
Published
2023-10-16
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
QXCDiabetes Digital Therapeutic Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QXCDiabetes Digital Therapeutic DeviceGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN220058000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN220058000BT-001Better Therapeutics2023-07-07QXC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860011146704PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011146704008600111467048600111467040860011146704

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
117816253
Device count
1
Lot or batch
true