FDA.reportPublic FDA data

TempoSmart

Primary DI
B553202174RX0
Brand
TempoSmart
Company
WELLDOC, INC.
Model
2.X
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
2024-04-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NDCCalculator, Drug Dose

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDCCalculator, Drug DoseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230813000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230813000BlueStar and BlueStar RxWelldoc, Inc.2023-07-28NDC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B553202174RX0PrimaryHIBCC0

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 intended to be used on a non-medical computerized device (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
B553202211OTC0Lilly Health Personalized Medicine and Health Platform2.X2026-04-21
B553202212OTC0Lilly Health Personalized Medicine and Health Platform2.X2026-04-21
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
B553202311OTC0Welldoc4.X2026-03-09
B553202312OTC0Welldoc4.X2026-03-09
B553202313OTC0Welldoc4.X2026-03-09
B553202301OTC0Welldoc3.X2025-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150002375MiniMed AppMEDTRONIC MINIMED, INC.NDC2026-05-25
00199150002382MiniMed AppMEDTRONIC MINIMED, INC.NDC2026-05-25
00860008440129iSage Rx Amalgam RX, Inc.NDC2026-04-22
B553202153OTC0Conifer Connect DiabetesWELLDOC, INC.NDC2026-03-30
00860015223906UpDocUpDoc Inc.NDC2026-01-13
B553202401OTC0Welldoc RxWELLDOC, INC.NDC2025-12-09
B553202402RX0Welldoc RxWELLDOC, INC.NDC2025-12-09
B553202403OTC0Welldoc RxWELLDOC, INC.NDC2025-12-09
B553202404RX0Welldoc RxWELLDOC, INC.NDC2025-12-09
B553202405RX0Welldoc RxWELLDOC, INC.NDC2025-12-09
00199150047000MiniMed 780G Insulin PumpMEDTRONIC MINIMED, INC.NDC2025-11-08
00199150047024MiniMed 780G Insulin PumpMEDTRONIC MINIMED, INC.NDC2025-11-08
00199150047048MiniMed 780G Insulin pumpMEDTRONIC MINIMED, INC.NDC2025-11-08
00199150047055MiniMed 780G Insulin PumpMEDTRONIC MINIMED, INC.NDC2025-11-08
07649994217037T1D1Comerge AGNDC2025-08-28
10385082000009Omnipod DASH PDMInsulet CorporationNDC2025-08-25
B553202251OTC0WelldocWELLDOC, INC.NDC2025-05-29
B553202252RX0WelldocWELLDOC, INC.NDC2025-05-29
B553202253OTC0WelldocWELLDOC, INC.NDC2025-05-29
B553202254RX0WelldocWELLDOC, INC.NDC2025-05-29
B553202256RX0WelldocWELLDOC, INC.NDC2025-05-29
00763000974589InPenMEDTRONIC MINIMED, INC.NDC2025-04-29
00763000974596InPenMEDTRONIC MINIMED, INC.NDC2025-04-29
B553202145RX0LivingConnected Diabetes RxWELLDOC, INC.NDC2025-04-11
00763000489953InPen Smart Insulin Delivery SystemMEDTRONIC MINIMED, INC.NDC2025-03-08
00763000489960InPen Smart Insulin Delivery SystemMEDTRONIC MINIMED, INC.NDC2025-03-08
00850005949558BioButton (Reprocessed)BIOINTELLISENSE, INC.NDC2025-02-19
00850005949565BioButton (Reprocessed, NF Version)BIOINTELLISENSE, INC.NDC2025-02-19
00860003340639EndoTool IV MONARCH MEDICAL TECHNOLOGIES LLCNDC2025-01-02
B553202141OTC0LivingConnected Diabetes RxWELLDOC, INC.NDC2024-12-04