FDA.reportPublic FDA data

QT ECG

Primary DI
04719872981503
Brand
QT ECG
Company
Qt Medical, Inc.
Model
QTERD100
Device description
The QT ECG system is a hand-held, cordless 12-lead electrocardiograph (ECG) system with Bluetooth connectivity.
Published
2023-06-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXHTransmitters And Receivers, Electrocardiograph, Telephone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXHTransmitters And Receivers, Electrocardiograph, TelephoneCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220795000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220795000QT ECGQT Medical, Inc.2022-09-26DXH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719872981473PackageGS150In Commercial Distribution
04719872981510PackageGS11In Commercial Distribution
04719872982098PackageGS11In Commercial Distribution
04719872981503PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719872981473047198729814734719872981473
04719872981510047198729815104719872981510
04719872982098047198729820984719872982098
04719872981503047198729815034719872981503

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiograph, home-useA device intended to be used by a layperson in the home to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It may be available with a variety of features [e.g., single-channel, multichannel, interpretive software, data telemetry]; electrodes may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-25 Degrees Celsius70 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity93 Percent (%) Relative Humidity

Contacts#

Phone, Email table
PhoneEmail
+1 909 323 0007service@qtmedical.com

Regulatory Flags#

DUNS number
078875059
Device count
1
DM exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719872981947QT ECGQTEOS125U2026-04-30
04719872981954QT ECGQTEOS126U2026-04-30
04719872981961QT ECGQTEOS127U2026-04-30
04719872981978QT ECGQTEOS121U2026-04-30
04719872981985QT ECGQTEOS122U2026-04-30
04719872981992QT ECGQTEOS123U2026-04-30
04719872982005QT ECGQTEOS124U2026-04-30
04719872982012QHeart SensorQTEOS120U2026-04-30
04719872981640QT ECGQTEOS129U2025-12-30
04719872981893QT ECGPCA-A2102025-12-30
04719872980261QT ECGPCA-C1012025-10-09
04719872980971QT ECGPCA-C101BL2025-10-09
04719872981701QT ECGPCA-C101BS2025-10-09
04719872981794QT ECGPCA-A1102025-10-09
04719872981589QT ECGPCA-C100BS2025-07-08
04719872981541QT ECGPCA-A1002025-07-08
04719872981558QT ECGPCA-A120L2025-07-08
04719872981565QT ECGPCA-A120S2025-07-08
04719872981572QT ECGPCA-A1302025-07-08
04719872981633QHeart SENSORQTEOS120U2025-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05419980589309FibriCheckQompiumDXH2026-05-06
05419980589316FibriCheckQompiumDXH2026-05-06
05419980589323FibriCheckQompiumDXH2026-05-06
05419980589347FibriCheckQompiumDXH2026-05-06
00195278343512CARESCAPE CENTRAL STATIONGe Medical Systems Information Technologies, Inc.DXH2026-02-11
00198953107263MACGe Medical Systems Information Technologies, Inc.DXH2026-01-27
07290008960380SmartheartSHL TELEMEDICINE INTERNATIONAL LTD.DXH2025-12-09
04719872981756QT ECGQt Medical, Inc.DXH2025-05-12
B353UB22511UbiqVue HolterLifesignals, Inc.DXH2025-04-22
B353UA2251R1UbiqVue Lifesignals, Inc.DXH2025-04-22
00195278421456CAMGE Medical Systems Information Technologies, Inc.DXH2025-04-07
00812324000297GEMS Mobile ECGCardioComm Solutions, IncDXH2025-03-20
B210AC0290K1000Alivecor, Inc.DXH2025-03-18
00840682144322MACGE Medical Systems Information Technologies, Inc.DXH2025-03-13
00860006382308SENSINEL™ CPM REPLACEMENT ADHESIVE PADAnalog Devices, Inc.DXH2025-03-13
00860006382315SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DXH2025-03-13
00860006382322SENSINEL™ CPM WEARABLEAnalog Devices, Inc.DXH2025-03-13
00860006382339SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.DXH2025-03-13
00860006382346SENSINEL™ CPM ALIGNMENT TOOLAnalog Devices, Inc.DXH2025-03-13
20860006382302SENSINEL™ CPM REPLACEMENT ADHESIVES (15 Pack)Analog Devices, Inc.DXH2025-03-13
08908013617128Frontier X PlusFOURTH FRONTIER TECHNOLOGIES PRIVATE LIMITEDDXH2025-02-07
00850043907046Zio ECG Utilization Software (ZEUS) SystemIRHYTHM TECHNOLOGIES, INC.DXH2024-07-26
04719872981527QT ECGQt Medical, Inc.DXH2024-07-08
04719872981534QT ECGQt Medical, Inc.DXH2024-07-08
00856298006428EZLink-RSCOTTCARE CORPORATION, THEDXH2024-05-23
00856298006435EZLink-CSCOTTCARE CORPORATION, THEDXH2024-05-23
B210AC0110KardiaBand SystemAlivecor, Inc.DXH2024-03-22
03700546708275Withings®WITHINGSDXH2023-09-07
03700546708435Withings®WITHINGSDXH2023-08-30
03700546708442Withings®WITHINGSDXH2023-08-30