Identity
- Trade Name
- TeleRehab Software File Manager FDA UDI
- Generic Name
- Electrocardiography telemetric monitoring system FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- TeleRehab Software File Manager FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- 101601 FDA UDI
- Primary DI / UDI-DI
- 00856298006244 FDA UDI
- 510(k) Number
- K050778 FDA UDI
- FDA Product Code
- DRG FDA UDI
- GMDN Term
- Electrocardiography telemetric monitoring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2910 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrocardiography telemetric monitoring system
TeleRehab Software File Manager by Scottcare Corporation, The — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrocardiography telemetric monitoring system.
- ER920W Life Support — Braemar Manufacturing, LLC · Class II
- BodyGuardian Mini Remote Monitoring System Kit — Preventice Services, LLC
- Continuous ECG Platform — VivaLNK, Inc. · Class II
- Heartrak Smart Rev 5 — UNIVERSAL MEDICAL, INC. · Class II
- ER9W CDMA First Call Med — Braemar Manufacturing, LLC · Class II
- Heartrak Smart Wireless Rev 1 — UNIVERSAL MEDICAL, INC. · Class II
- RhythmStar — RhythMedix, LLC · Class II
- RescueNet 12-Lead — Zoll Medical Corporation · Class II
Cleared under the same submission
K050778 also covers:
- Angel — SCOTTCARE CORPORATION, THE
- Innovo — SCOTTCARE CORPORATION, THE
- TeleRehab Computer — SCOTTCARE CORPORATION, THE
- TeleRehab Rack Server — SCOTTCARE CORPORATION, THE
- TeleRehab Receiver Box — SCOTTCARE CORPORATION, THE
- TeleRehab Receiver Card — SCOTTCARE CORPORATION, THE
- TeleRehab Software Work Station/Seat License — SCOTTCARE CORPORATION, THE
- Telemetry 3 Lead Patient Cable — SCOTTCARE CORPORATION, THE
- Telemetry 5 Lead Patient Cable — SCOTTCARE CORPORATION, THE
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Scottcare Corporation, The
Sources (1)
- FDA UDI 9ff195ca-21b7-4e93-837f-0b1674f91fbc 36 fields · synced May 31, 2026