FDA.reportPublic FDA data

TeleRehab Software Work Station/Seat License

Primary DI
00856298006251
Brand
TeleRehab Software Work Station/Seat License
Company
SCOTTCARE CORPORATION, THE
Model
TeleRehab Software Work Station/Seat License
Catalog number
101608
Device description
The ScottCare VersaCare Cardiopulmonary Monitoring System is designed to allow monitoring andrecording of electrocardiograph (ECG) rhythm strips and related information for patients undergoingan exercise therapy program. Patients are monitored by medical telemetry exercise monitoringequipment. This feature allows patients to comply with exercise prescriptions while exercising at amedical/rehabilitation facility near their home, or by returning to the primary medical facility toparticipate in an in-house cardiopulmonary rehabilitation program. VersaCare includes a ProgramManagement module that prints a variety of reports.
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K050778000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050778000TELEREHAD 2004Scottcare2005-04-13DRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856298006251PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856298006251008562980062518562980062510856298006251

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

Contacts#

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

Regulatory Flags#

DUNS number
808204957
Device count
1
Lot or batch
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
00856298006022TeleSenseRCMMCT17741018382016-09-19
00856298006039TeleSense-EE17741018392016-09-19
00856298006220Chroma 5 Lead Patient Cable1006052017-01-23

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Primary DI, Brand, Company table
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