FDA.reportPublic FDA data

Commwell

Primary DI
07290012672026
Brand
Commwell
Company
COMMWELL RESEARCH & DEVELOPMENT LTD.
Model
PhysioGlove ET System
Catalog number
5-056-00
Device description
An instrument designed to measure electrical potentials on the body surface to generate a record of the electrical currents associated with heart muscle activity [i.e., an electrocardiogram (ECG)] for the assessment of cardiac physiology. It records electrical signals from 12 leads simultaneously, thus simplifying and facilitating the interpretation of the record by enabling the comparison of 12-lead recording of the same heartbeat. It records data in electronic or printed form for Bluetooth transmission to a mobile device for later Wi-Fi or GSM transmission to a predefined web server for analysis by software or by a healthcare professional.
Published
2017-01-25
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
DPSElectrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133703000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133703000PHYSIOGLOVE ET SYSTEMCommwell R&D , Ltd.2014-08-18DXH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290012672026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290012672026072900126720267290012672026

GMDN Terms#

Term, Definition table
TermDefinition
Multichannel electrocardiograph, noninterpretiveAn instrument designed to measure electrical potentials on the body surface to generate a record of the electrical currents associated with heart muscle activity [i.e., an electrocardiogram (ECG)] for the assessment of cardiac physiology. It records electrical signals from two or more multiple electrode sets (leads) simultaneously, thus simplifying and facilitating the interpretation of the record by enabling the comparison of multiple-lead recording of the same heartbeat. It records data in electronic or printed form for later analysis by software or a healthcare professional.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
532013976
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290012672057CommwellRPCS50005-001-002017-01-26
07290012672064CommwellECG Mgmt Sys with ECG Analysis5-058-002017-01-26
07290012672019CommwellES-ECG System5-045-002017-01-25

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Primary DI, Brand, Company table
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