FDA.reportPublic FDA data

Q Patch Mobile Application

Primary DI
05903021560155
Brand
Q Patch Mobile Application
Company
MEDICALGORITHMICS S A
Model
1.0
Device description
Q Patch Mobile Application (Mobile application) – The Q Patch Mobile Application is intended to be used for interacting with the Q Patch recorder for transmission patient data to set up ECG recording session and displaying the Q Patch’s status. The application is obligatory for healthcare professionals and optional for patients
Published
2022-06-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MWJElectrocardiograph, Ambulatory (Without Analysis)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MWJElectrocardiograph, Ambulatory (Without Analysis)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210758000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210758000Q PatchMedicalgorithmics S.A.2022-06-02MWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05903021560155PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05903021560155059030215601555903021560155

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiography telemetric monitoring systemAn assembly of devices designed to continuously measure and wirelessly transmit electrocardiographic (ECG) signals from a patient to a receiving location (e.g., central station, bedside monitor) for viewing. It typically consists of a portable transmitter with antenna and attached sensors (e.g., leads and electrodes) that are connected to the patient, as well as a receiver typically incorporated into a central station or bedside monitor that receives, consolidates, and displays the information. The system is typically used for ambulatory patients who require continuous monitoring (e.g., patients in step-down care areas).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
522657576
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05903021560834DeepRhythmAIType: DRAI2026-03-25
05903021560742DeepRhythmAIType: DRAI2025-06-06
05903021560223PocketECG IV - Unified Arrhythmia Diagnostic SystemP3HL-AB-UNI2025-12-04
05903021560001Medicalgorithmics Unified Arrhythmia Diagnostic System PocketECGType: PC Client2017-12-18
05903021560131DeepRhythmAIType: DRAI2022-08-05
05903021560018PocketECG III – Medicalgorithmics Unified Arrhythmia Diagnostic SystemType: PECGT-III2018-01-09
05903021560025PocketECG III – Medicalgorithmics Unified Arrhythmia Diagnostic SystemType: PECGT-IIIV2018-01-09
05903021560032PocketECG III – Medicalgorithmics Unified Arrhythmia Diagnostic SystemType: PECGB-III2018-01-09
05903021560049PocketECG III – Medicalgorithmics Unified Arrhythmia Diagnostic SystemType: PECGC-III2018-01-09
05903021560056PocketECG CRS - Medicalgorithmics Unified Cardiac Rehabilitation SystemType: PECGT-IIIR2018-08-21
05903021560698DeepRhythm PlatformDeepRhythm Platform2024-12-20
05903021560124Q PatchP5HP-AA-ADS2022-06-23
05903021560162Q Patch Downloader9.482022-06-23
05903021560070PocketECG IV – Unified Arrhythmia Diagnostic SystemP4TR-AA-ADS2020-08-14
05903021560087PocketECG IV – Unified Arrhythmia Diagnostic SystemP4TR-AB-ADS2020-08-14
05903021560094PocketECG IV – Unified Arrhythmia Diagnostic SystemP4BA-AA-UNI2020-08-14
05903021560100PocketECG IV – Unified Arrhythmia Diagnostic SystemP3CH-AB-UNI2020-08-14
05903021560117PocketECG IV – Unified Arrhythmia Diagnostic SystemP4BA-AB-UNI2020-08-14
05903021560063PocketECG III – Medicalgorithmics Unified Arrhythmia Diagnostic SystemType: PECGH-III2018-08-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250903203381CardioMem getemed Medizin- und Informationstechnik AGMWJ2026-05-01
00850064210309ANNE Chest Adhesive - Gentle Wear Shelf BoxSibel Health Inc.MWJ2025-12-17
10841522131349Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-09
10841522131356Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-09
10841522131363Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-09
10841522131387Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-09
10841522131394Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-09
10841522131400Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-09
10841522131370Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-10-01
10841522131639Eclipse MiniSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-09-29
10841522131417Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-09-03
10841522131424Spacelabs HealthcareSPACELABS HEALTHCARE (WASHINGTON), INCMWJ2025-09-03
B353UB12511UbiqVue HolterLifesignals, Inc.MWJ2025-04-22
00850064210200Sibel Spacelabs Trek Chest PatchSibel Health Inc.MWJ2025-04-02
00850064210224Sibel Spacelabs Trek ChargerSibel Health Inc.MWJ2025-04-02
00850064210248Sibel Spacelabs Trek Chest Patch AdhesiveSibel Health Inc.MWJ2025-04-02
00860004541745ANNE ChestSibel Health Inc.MWJ2025-04-02
00850064210002ANNE Chest Sensor KitSibel Health Inc.MWJ2025-03-26
008500642100197-Day ANNE Chest Adhesive PouchSibel Health Inc.MWJ2025-03-26
008500642100261-Day ANNE Chest Adhesive PouchSibel Health Inc.MWJ2025-03-26
00850064210057ANNE Bedside Wireless ChargerSibel Health Inc.MWJ2025-03-26
008500642101017-Day ANNE Chest Adhesive Shelf BoxSibel Health Inc.MWJ2025-03-26
00850064210149ANNE Chest SensorSibel Health Inc.MWJ2025-03-26
04250903200991SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-14
04250903201011SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-14
04250903201035SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-14
04250903200878SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-04
04250903200892SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-04
04250903200915SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-04
04250903201080SEER 1000getemed Medizin- und Informationstechnik AGMWJ2025-03-04