TeleRehab Software File Manager 101601

GUDID 00856298006244

The ScottCare VersaCare Cardiopulmonary Monitoring System is designed to allow monitoring and recording of electrocardiograph (ECG) rhythm strips and related information for patients undergoing an exercise therapy program. Patients are monitored by medical telemetry exercise monitoring equipment. This feature allows patients to comply with exercise prescriptions while exercising at a medical/rehabilitation facility near their home, or by returning to the primary medical facility to participate in an in-house cardiopulmonary rehabilitation program. VersaCare includes a Program Management module that prints a variety of reports.

SCOTTCARE CORPORATION, THE

Electrocardiography telemetric monitoring system

• Primary Device ID: 00856298006244
• NIH Device Record Key: 9ff195ca-21b7-4e93-837f-0b1674f91fbc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TeleRehab Software File Manager
• Version Model Number: TeleRehab Software File Manager
• Catalog Number: 101601
• Company DUNS: 808204957
• Company Name: SCOTTCARE CORPORATION, THE
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 216-362-0550
• Email: service@scottcare.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856298006244 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050778

FDA Product Code

• DRG: Transmitters And Receivers, Physiological Signal, Radiofrequency

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-19

Devices Manufactured by SCOTTCARE CORPORATION, THE

• 00856298006008 - Chroma: 2019-11-08 The Chroma model RZ153C Holter monitor is a battery operated solid-state recorder. It is designed for up to 48 hours (2 days) co
• 00856298006015 - Chroma2: 2019-11-08
• 00856298006022 - TeleSenseRCM: 2019-11-08 The TeleSense device is intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events
• 00856298006039 - TeleSense-E: 2019-11-08 The TeleSense device is intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events
• 00856298006220 - Chroma 5 Lead Patient Cable: 2019-11-08 5 lead ECG patient cable to be used with the Chroma device.
• 00856298006312 - Chroma 7 Lead Patient Cable: 2019-11-08 7 lead ECG patient cable to be used with the Chroma device.
• 00856298006053 - Angel: 2019-05-07 Cardiac Rehab ECG telemetry transmitter.
• 00856298006060 - Innovo: 2019-05-07 Cardiac Rehab ECG telemetry transmitter.