Data / Medical devices / United States / Teladoc Health, Inc. - Lewisville
Teladoc Health, Inc. - Lewisville: FDA-registered device maker in Lewisville, TX, United States, 7 510(k) clearances
Teladoc Health, Inc. - Lewisville is registered with the FDA (registration 3021611414) in Lewisville, TX, United States. It lists 10 device types. The FDA files 7 510(k) clearances under its listings, the newest dated January 30, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3021611414
- Address
- 1945 Lakepointe Drive, Lewisville, TX, United States, 75057
- Owner or operator
- Teladoc Health, Inc. (10047465)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- September 11, 2014
- Registered through
- 2027
- Brand names listed
- Livongo BGMS, Livongo Blood Glucose Meter, Livongo Blood Glucose Monitoring System, Livongo Blood Glucose Test Strips, Livongo Control Solution, Livongo DMS, Livongo Data Management System, Livongo Lancets and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 30, 2025 | K243060 | TeleRPM Gen2 Blood Glucose Monitoring System | NBW | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. | accessdata.fda.gov |
| August 21, 2024 | K241351 | Blood Pressure Monitor (TMB-2092-G) | DXN | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. | accessdata.fda.gov |
| July 6, 2022 | K220475 | Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T) | QRL | Substantially Equivalent | Tianjin Huahong Technology Co., Ltd. | accessdata.fda.gov |
| March 9, 2021 | K202891 | Blood Pressure Monitor | DXN | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. | accessdata.fda.gov |
| March 27, 2018 | DEN170088 | Dexcom G6 Continuous Glucose Monitoring System | QBJ | Unknown | Dexcom, Inc. | accessdata.fda.gov |
| September 8, 2014 | K133584 | IN TOUCH BLOOD GLUCOSE MONITORING SYSTEM | CGA | Substantially Equivalent | Eoshealth, Inc. | accessdata.fda.gov |
| June 19, 2013 | K131395 | TRANSTEK BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Analyzer, Body Composition, Exempt
- All makers of Scale, Stand-On, Patient
- All makers of System, Test, Blood Glucose, Over The Counter
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of Glucose Oxidase, Glucose
Updated January 30, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.