Health Optimizer

Primary DI
B5530701001OTC0
Brand
Health Optimizer
Company
WELLDOC, INC.
Model
4.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
2026-10-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
B5530701001OTC0PrimaryHIBCC0

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B5530702001OTC0Health Optimizer4.X2026-10-14
B5530703001OTC0Health Optimizer4.X2026-10-14
B5530801001OTC0Health Optimizer for Rare Condition Members4.X2026-10-14
B5530802001OTC0Health Optimizer for Rare Condition Members4.X2026-10-14
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
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
B552202153OTC0Conifer Connect Diabetesv1.X2024-08-28
B553202145RX0LivingConnected Diabetes Rxv1.X2025-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B5530702001OTC0Health OptimizerWELLDOC, INC.MRZ2026-10-14
B5530703001OTC0Health OptimizerWELLDOC, INC.MRZ2026-10-14
04046955582969Perfusor®B. BRAUN MEDICAL INC.MRZ2026-06-07
04046955739721SPACEB. BRAUN MEDICAL INC.MRZ2026-04-11
B553202291OTC0Health OptimizerWELLDOC, INC.MRZ2026-03-30
B553202292OTC0Health OptimizerWELLDOC, INC.MRZ2026-03-30
B553202293OTC0Health OptimizerWELLDOC, INC.MRZ2026-03-30
00085412718378Spectrum Wireless BatteryBAXTER HEALTHCARE CORPORATIONMRZ2025-10-10
00085412947914Spectrum Wireless BatteryBAXTER HEALTHCARE CORPORATIONMRZ2025-10-10
G001RG31RGChengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.MRZ2025-06-27
00840365902096InvenioGri-Alleset, Inc.MRZ2025-03-12
10840365902093InvenioGRI Medical & Electronic Technology Co., Ltd.MRZ2025-03-12
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17290109152629Avoset Pouch ProEITAN MEDICAL LTDMRZ2024-07-23
2729010915261950/100 Avoset PouchEITAN MEDICAL LTDMRZ2024-07-23
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B553202191OTC0Health OptimizerWELLDOC, INC.MRZ2024-07-05
B553202192OTC0Health OptimizerWELLDOC, INC.MRZ2024-07-05
B553202193OTC0Health OptimizerWELLDOC, INC.MRZ2024-07-05
B553202091OTC0Health OptimizerWELLDOC, INC.MRZ2024-03-28
B553202092OTC0Health OptimizerWELLDOC, INC.MRZ2024-03-28
17290109151653PCA Lockbox 250 Strap and PouchEITAN MEDICAL LTDMRZ2024-03-19
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17290109154104Travel CaseEITAN MEDICAL LTDMRZ2024-03-03
27290109154101Travel CaseEITAN MEDICAL LTDMRZ2024-03-03
B553202093OTC0Health OptimizerWELLDOC, INC.MRZ2024-01-26
B553HLTHOPTIMIZER190Health OptimizerWELLDOC, INC.MRZ2024-01-26
B553HLTHOPTIMIZER180Health OptimizerWELLDOC, INC.MRZ2023-11-17