Pulse by EHE Health

GUDID B553PULSE100

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.

WELLDOC, INC.

Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Pharmaceutical management support software, patient-/professional-use Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software Home pharmaceutical management support software
Primary Device IDB553PULSE100
NIH Device Record Key75e75793-fae0-4214-ba9c-4abf1ec8f78a
Commercial Distribution StatusIn Commercial Distribution
Brand NamePulse by EHE Health
Version Model Numberv1.0
Company DUNS021217115
Company NameWELLDOC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com
Phone18886114794
Emailconnect@welldoc.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB553PULSE100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MRZAccessories, Pump, Infusion

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-10
Device Publish Date2022-05-02

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B553202091OTC0 - Health Optimizer2024-04-05 Health Optimizer® is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have
B553202092OTC0 - Health Optimizer2024-04-05 Health Optimizer® is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have
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