FDA.reportPublic FDA data

Q Patch

Primary DI
05903021560124
Brand
Q Patch
Company
MEDICALGORITHMICS S A
Model
P5HP-AA-ADS
Device description
The Q Patch is a single channel ECG recorder. The device is intended to be placed on the sternum (in the middle of the chest). The Q Patch ECG recorder snaps onto the two off-the-shelf electrodes (Solid gel, Ag/AgCl) and records patient’s ECG for up to 15 days powered from single disposable, non-rechargeable battery. The Q Patch Mobile Application is used to initiate recording session, for checking Q Patch status and to finish/stop the session if needed. When the recording is finished, the ECG data stored in Q Patch’s memory can be downloaded through a USB port using the Q Patch Downloader (PC application).
Published
2022-06-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
05903021560124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05903021560124059030215601245903021560124

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).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius45 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
522657576
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
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
05903021560155Q Patch Mobile Application1.02022-06-23
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
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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