Welldoc

GUDID B553202303OTC0

The Welldoc App is Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCP) and their patients – aged 18 years and older – who have prediabetes, diabetes, heart failure, high blood pressure, liver disease, kidney disease, and/or sleep apnea. The Welldoc App also supports weight management and mental wellbeing. The patient software, running on a mobile phone, collects health data, promotes healthy behavior, and encourages adherence to treatment plans and self-monitoring practices as advised by a HCP. The software also generates electronic reports intended for a HCP. The web-based HCP software allows HCPs to view patient health data and communicate directly with their patients. The software provides secure transfer, storage, and secondary display of data from devices such as continuous glucose monitors (CGM), blood glucose meters, blood pressure monitors, activity trackers, and weight scales as well as self-reported health information. The software also performs retrospective analysis of CGM data which may be used by people with diabetes and their HCP when determining therapeutic strategies. The software provides educational content to encourage behaviors which may help living well with cardiometabolic conditions based on guidance from healthcare professional organizations. This may include promoting healthy lifestyle choices such as getting enough sleep, eating a balanced diet, maintaining a healthy weight, and promoting physical activity. The software is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment nor is it intended to replace self-monitoring practices as advised by a physician. The software does not provide treatment recommendations.

WELLDOC, INC.

Self-care monitoring/reporting software
Primary Device IDB553202303OTC0
NIH Device Record Key65ff1b7a-1d43-4e95-aa75-cebbd6acde69
Commercial Distribution StatusIn Commercial Distribution
Brand NameWelldoc
Version Model Number3.X
Company DUNS021217115
Company NameWELLDOC, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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

Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com
Phone1-888-611-4794
Emailconnect@welldoc.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB553202303OTC0 [Primary]

FDA Product Code

PHVContinuous Glucose Monitor Retrospective Data Analysis Software

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-29
Device Publish Date2025-07-21

On-Brand Devices [Welldoc]

B553WELLDOC100Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged
B553WELLDOC110Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged
B553WELLDOCRX120Welldoc Diabetes Rx is indicated for use by healthcare providers (HCPs) and their patients – a
B553WELLDOC120Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged
B553WELLDOCRX130Welldoc Diabetes Rx is indicated for use by healthcare providers (HCPs) and their patients – a
B553WELLDOC130Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged
B553WELLDOCRX140Welldoc Diabetes Rx is indicated for use by healthcare providers (HCPs) and their patients – a
B553WELLDOC140Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged
B553WELLDOCRX200Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged
B553WELLDOC200Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged
B553202056RX0Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged
B553202054RX0Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged
B553202053OTC0Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged
B553202052RX0Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged
B553202051OTC0Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged
B553202256RX0Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged
B553202254RX0Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged
B553202253OTC0Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged
B553202252RX0Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged
B553202251OTC0Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged
B553202303OTC0The Welldoc App is Software as a Medical Device (SaMD) intended to be used by healthcare provide
B553202302OTC0The Welldoc App is Software as a Medical Device (SaMD) intended to be used by healthcare provide
B553202301OTC0The Welldoc App is Software as a Medical Device (SaMD) intended to be used by healthcare provide

Trademark Results [Welldoc]

Mark Image

Registration | Serial
Company
Trademark
Application Date
WELLDOC
WELLDOC
88808718 not registered Live/Pending
Welldoc, Inc.
2020-02-24
WELLDOC
WELLDOC
77115970 3534689 Live/Registered
WellDoc Communications, Inc.
2007-02-26
WELLDOC
WELLDOC
76692952 4206117 Live/Registered
WELLDOC, INC.
2008-09-18

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.