FDA.reportPublic FDA data

TempoSmart

Primary DI
B553TEMPOSMART110
Brand
TempoSmart
Company
WELLDOC, INC.
Model
v1.1
Device description
TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to assist patients in managing their diabetes with guidance from their providers.
Published
2023-08-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
LNXMedical Computers And Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNXMedical Computers And Software

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190013000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190013000WellDoc BlueStarWelldoc, Inc.2019-11-04MRZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B553TEMPOSMART110PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Home pharmaceutical management support softwareA software package intended to be used by patients at home, and healthcare professionals in a clinical setting, to facilitate therapeutic pharmaceutical management decisions (e.g., dosage) by providing suggested regimes for individual patients based on their physical and laboratory data. It is available as a locally-installed program, Internet-based and/or mobile application (e.g., to be used on mobile devices at point-of-care); it is not intended to support anaesthesia administration.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021217115
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B5531401001OTC0Lilly Health Personalized Medicine and Health Platform3.X2026-07-17
B5531402001OTC0Lilly Health Personalized Medicine and Health Platform3.X2026-07-17
B553202211OTC0Lilly Health Personalized Medicine and Health Platform2.X2026-04-21
B553202212OTC0Lilly Health Personalized Medicine and Health Platform2.X2026-04-21
B553BYRAMCONNECT100ByramConnectv1.02021-09-27
B553BYRAMCONNECTRX100ByramConnect Rxv1.02021-09-27
B553202201OTC0Lilly Health Personalized Medicine and Health Platform1.X2025-06-03
B553202202OTC0Lilly Health Personalized Medicine and Health Platform1.X2025-05-28
B553202153OTC0Conifer Connect Diabetesv1.X2026-03-30
B553202291OTC0Health Optimizer3.X2026-03-30
B553202292OTC0Health Optimizer3.X2026-03-30
B553202293OTC0Health Optimizer3.X2026-03-30
B553202294OTC0Health Optimizer for Rare Condition Members3.X2026-03-30
B553202295OTC0Health Optimizer for Rare Condition Members3.X2026-03-30
B552202153OTC0Conifer Connect Diabetesv1.X2024-08-28
B553202145RX0LivingConnected Diabetes Rxv1.X2025-04-11
B553202141OTC0LivingConnected Diabetes Rxv1.X2024-12-04
B553202142RX0LivingConnected Diabetesv1.X2024-12-04
B553202143OTC0LivingConnected Diabetesv1.X2024-12-04
B553202144RX0LivingConnected Diabetes Rxv1.X2024-12-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816486021015SaltilloPRENTKE ROMICH COMPANYLNX2023-11-08
B553TEMPOINSIGHTS110Tempo InsightsWELLDOC, INC.LNX2023-08-07
B553TEMPOINSIGHTS100Tempo InsightsWELLDOC, INC.LNX2022-12-12
B553TEMPOSMART100TempoSmartWELLDOC, INC.LNX2022-12-12