FDA.reportPublic FDA data

Pulse Rx by EHE Health

Primary DI
B553PULSERX100
Brand
Pulse Rx by EHE Health
Company
WELLDOC, INC.
Model
v1.0
Device description
Pulse Rx 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 Rx 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
Rx
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
B553PULSERX100PrimaryHIBCC0

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
18886114794conncet@welldoc.com

Regulatory Flags#

DUNS number
021217115
Device count
1
Lot or batch
true
Contains natural rubber latex
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

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Primary DI, Brand, Company table
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