FDA.reportPublic FDA data

Pulse by EHE Health

Primary DI
B553PULSE100
Brand
Pulse by EHE Health
Company
WELLDOC, INC.
Model
v1.0
Device description
Pulse by EHE Health (“Pulse”) 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. Pulse is intended to assist patients in managing their diabetes with guidance from their providers.
Published
2022-05-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
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
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
B553PULSE100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Pharmaceutical management support software, patient-/professional-useA software package intended to be used by both 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

Contacts#

Phone, Email table
PhoneEmail
18886114794connect@welldoc.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
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
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
07290109155296Sapphire PCA Lockbox 500mL Label EITAN MEDICAL LTDMRZ2024-11-29
15019517375244CADDICU MEDICAL, INC.MRZ2024-10-14
1729010915261250/100 Avoset PouchEITAN MEDICAL LTDMRZ2024-07-23
17290109152629Avoset Pouch ProEITAN MEDICAL LTDMRZ2024-07-23
2729010915261950/100 Avoset PouchEITAN MEDICAL LTDMRZ2024-07-23
27290109152626Avoset Pouch ProEITAN MEDICAL LTDMRZ2024-07-23
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
27290109151650PCA Lockbox 250 Strap and PouchEITAN MEDICAL LTDMRZ2024-03-19
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
00850025535502UTC 3ml Medication CartridgeGilero, LLCMRZ2023-09-25
17290109154708Sapphire Power Supply - USEITAN MEDICAL LTDMRZ2023-09-05
27290109154705Sapphire Power Supply - USEITAN MEDICAL LTDMRZ2023-09-05