Teladoc Health, Inc. - Lewisville

FDA Device Registration & Listing · Lewisville, TX, US · Registration 3021611414

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3021611414
FEI Number
3021611414
Entity Name
Teladoc Health, Inc. - Lewisville
City/State/Country
Lewisville, TX, US
Establishment Address
1945 LAKEPOINTE DRIVE, Lewisville, TX 75057, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Teladoc Health, Inc. (Owner Number: 10047465)
Owner / Operator Contact Address
1945 Lakepointe Drive, Lewisville, TX 75057, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K220475
PMA Number
N/A

All Registered Proprietary Names

Livongo App Retrospective CGM Data Analysis Teladoc Health App Retrospective CGM Data Analysis

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2026-01-14
FRI Scale, Stand-On, Patient General Hospital Class 1 880.2700 2019-06-11
QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated Clinical Chemistry Class 2 862.1355 2023-07-31
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2020-01-10
PUH Analyzer, Body Composition, Exempt Cardiovascular Class 2 870.2770 2019-01-28
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2023-03-28
PHV Continuous Glucose Monitor Retrospective Data Analysis Software Clinical Chemistry Class 1 862.2120 2025-12-09
QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2026-01-14
QRL Multiple Use Blood Lancet For Single Patient Use Only General, Plastic Surgery Class 2 878.4850 2026-01-14

Official Correspondent

Ileana Davis

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Teladoc Health, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K103744 Quantimetrix Corp. DROPPER A1C DIABETES CONTROL 2011-05-12
K981281 Roche Diagnostics GmbH ELECSYS CALCHECK FERRITIN 1998-04-24
K981278 Roche Diagnostics GmbH ELECSYS CALCHECK CA 125II 1998-04-23
K143687 Siemens Healthcare Diagnostics, Inc. ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material 2015-07-17
K143376 Siemens Healthcare Diagnostics, Inc. ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material 2014-12-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2008 Tosoh Bioscience Inc 1
4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.
Z-0032-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.

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1319681 ORTHO-CLINICAL DIAGNOSTICS, INC. Rochester, NY, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021611414. Last updated year: 2026. Please use registration number 3021611414 when referencing this establishment in official correspondence.
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