FDA.reportPublic FDA data

TeleSenseRCM

Primary DI
00856298006022
Brand
TeleSenseRCM
Company
SCOTTCARE CORPORATION, THE
Model
MCT1774
Catalog number
101838
Device description
The TeleSense device is intended for diagnostic evaluation of patients who experience transient symptoms orasymptomatic events that may suggest cardiac arrhythmia. The device continuously monitors and records thedata, automatically records events triggered by an arrhythmia detection algorithm or manually by the patient, andautomatically transmits the recorded event activity associated with these symptoms for review by a licensedphysician.The TeleSense is a battery powered device to be used to measure, record, store and/or remotely transfer theElectrocardiogram (ECG) noninvasively in mobile patients. The available data transfer methods are USB and Wi-Fi.TeleSense is not limited to certain patient groups or pathologies; however, the TeleSense is not intended forpediatric use. Examples of applications are:- Cardiology- Pulmonary Care- Home Care- General PractitionersContraindications:a. Patients with potentially life-threatening arrhythmias who require inpatient monitoring.b. Patients who the attending physician thinks should be hospitalized.
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRGTransmitters And Receivers, Physiological Signal, Radiofrequency

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142180000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142180000TELESENSEScottcare Corporation2014-12-12DSI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856298006022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856298006022008562980060228562980060220856298006022

GMDN Terms#

Term, Definition table
TermDefinition
Telemetric electrocardiographic ambulatory recorderAn electrically-powered, noninvasive device designed to be worn by a patient during daily activities for 24-hour recording of the electrocardiographic signals of the heart, for the diagnosis of cardiac disorders (e.g., arrhythmias). The recorded measurements can be wirelessly transmitted and analysed, typically to a remote computer with a dedicated software located at a medical facility. Otherwise known as a Holter monitor, the device typically incorporates display and controls, and may include surface electrodes, lead wires and accessories intended for attachment/removal (e.g., wipes, adhesive remover).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-20 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature-20 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
216-362-0550service@scottcare.com

Regulatory Flags#

DUNS number
808204957
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856298006411AermosAermos System2025-10-28
00856298006428EZLink-REZLink-R1032012024-05-23
00856298006435EZLink-CEZLink-C1032002024-05-23
00856298006282TeleRehab Receiver BoxTR6201011272016-09-19
00856298006299TeleRehab Receiver CardTeleRehab Receiver Card1000072016-09-19
00856298006114Transtelephonic Receiving ModuleTranstelephonic Receiving Module1001512016-09-19
00856298006046TeleSentry BatteryTS01101109B2017-01-11
00856298006077Telemetry 3 Lead Patient CableTelemetry 3 Lead Patient Cable1002332016-09-19
00856298006084Telemetry 5 Lead Patient CableTelemetry 5 Lead Patient Cable1002342016-09-19
00856298006091Chroma2 5 Lead Patient CableChroma2 5 Lead Patient Cable2016-09-19
00856298006107Chroma2 7 Lead Patient CableChroma2 7 Lead Patient Cable1019282016-09-19
00856298006121TeleSentry 3 Lead Patient CableTeleSentry 3 Lead Patient Cable1001722016-09-19
00856298006138"TeleSense 3 Lead Patient Cable 30""""TeleSense 3 Lead Patient Cable 30"""1018262016-09-19
00856298006145"TeleSense 3 Lead Patient Cable 40""""TeleSense 3 Lead Patient Cable 40"""1018732016-09-19
00856298006275TeleRehab ComputerTeleRehab Computer1018192016-09-19
00856298006008ChromaRZ153C1012732016-09-19
00856298006015Chroma2RZ153C21019422016-09-19
00856298006039TeleSense-EE17741018392016-09-19
00856298006220Chroma 5 Lead Patient Cable1006052017-01-23
00856298006312Chroma 7 Lead Patient Cable1006082017-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.DRG2026-06-02
04719875011016EZYPRO ECG RecorderSIGKNOW BIOMEDICAL CO., LTD.DRG2026-06-01
04719875011023EZYPRO ECG RecorderSIGKNOW BIOMEDICAL CO., LTD.DRG2026-06-01
04719875011030EZYPRO ECG RecorderSIGKNOW BIOMEDICAL CO., LTD.DRG2026-06-01
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700048020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700048040WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700048050WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700048060WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700048070WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700048080WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700048090WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
00195278990914Portrait CSSXBGe Medical Systems Information Technologies, Inc.DRG2025-12-10
00198953024096Portrait CVAXBGe Medical Systems Information Technologies, Inc.DRG2025-12-10
00198953030981PORTRAIT HSWXBGE Healthcare Finland OyDRG2025-12-10
B353UB12511UbiqVue HolterLifesignals, Inc.DRG2025-04-22
B353UB22511UbiqVue HolterLifesignals, Inc.DRG2025-04-22