Telerehad 2004
by Scottcare
510(k) K050778
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK050778 | Date13 Apr 2005 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DRG
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2910
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The TeleRehab 2004 is a Transmitter and Receiver, Physiological Signal, Radiofrequency device designed for telemetry monitoring in cardiac and pulmonary rehabilitation. It acquires and conditions electrocardiogram (ECG) signals from ambulatory adult patients, transmitting data wirelessly via radiofrequency to a central workstation for clinical assessment.
This system is intended for use in hospital or clinical settings, operated by clinicians. It consists of a signal transmitter, receiver, and workstation computers. The device is classified as Class II under FDA regulation 870.2910, with a 510(k) clearance (K050778) granted in 2005. It is intended for single-use or reusable applications as specified by the manufacturer, though sterility and MRI safety details are not provided in the data.
Other devices from Scottcare
Questions
AI-generated answers, 1 Oct 2026
What is the TeleRehab 2004 used for in clinical settings?
The TeleRehab 2004 is designed for telemetry monitoring in cardiac and pulmonary rehabilitation programs. It acquires and conditions electrocardiogram (ECG) signals from ambulatory adult patients, transmitting data wirelessly via radiofrequency to a central workstation. This allows clinicians to remotely assess patient vitals in real time, improving safety and efficiency during rehabilitation sessions.
How is the TeleRehab 2004 system supplied and what does it include?
The TeleRehab 2004 system consists of three primary components: a signal transmitter, a receiver, and workstation computers. The transmitter captures ECG signals from patients, while the receiver decodes and forwards the data to the workstation for analysis. The system is intended for use in hospital or clinical environments, where clinicians operate and interpret the transmitted physiological data.
Is the TeleRehab 2004 intended for single-use or reusable applications?
The TeleRehab 2004 can be used either as a single-use or reusable device, depending on the manufacturer’s specifications for each component. While the data does not specify sterility or MRI safety details, the flexibility in usage allows facilities to choose based on their infection control protocols and operational needs.
What regulatory pathway does the TeleRehab 2004 follow?
The TeleRehab 2004 is classified as a Class II medical device under FDA regulation 870.2910 and holds a 510(k) clearance (K050778) granted in 2005. This clearance indicates that the device was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets FDA safety and effectiveness requirements for its intended use in telemetry monitoring.
Can the TeleRehab 2004 be used in non-hospital settings?
The TeleRehab 2004 is explicitly intended for use in hospital or clinical settings, as outlined in its description. While the wireless transmission capability enables remote monitoring, the system is not designed for home use or non-medical environments. Facilities must ensure proper setup and clinician supervision for accurate and safe operation.