Health Optimizer

Primary DI
B553202292OTC0
Brand
Health Optimizer
Company
WELLDOC, INC.
Model
3.X
Device description
Health Optimizer™ is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Health Optimizer is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Health Optimizer analyzes and reports blood glucose test results and supports medication adherence. In addition, Health Optimizer provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. Health Optimizer is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
Published
2026-03-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MRZAccessories, Pump, Infusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRZAccessories, Pump, InfusionGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193654000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193654000BlueStar RxWelldoc, Inc.2020-04-07MRZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B553202292OTC0PrimaryHIBCC0

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.

Contacts#

Phone, Email table
PhoneEmail
+1(888)450-3664connect@welldocinc.com

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
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
B553202302OTC0Welldoc3.X2025-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04046955739721SPACEB. BRAUN MEDICAL INC.MRZ2026-04-11
B553202291OTC0Health OptimizerWELLDOC, INC.MRZ2026-03-30
B553202293OTC0Health OptimizerWELLDOC, INC.MRZ2026-03-30
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00840365902096InvenioGri-Alleset, Inc.MRZ2025-03-12
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27290109152626Avoset Pouch ProEITAN MEDICAL LTDMRZ2024-07-23
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B553202192OTC0Health OptimizerWELLDOC, INC.MRZ2024-07-05
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17290109154104Travel CaseEITAN MEDICAL LTDMRZ2024-03-03
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