EasyTeleMed (2.0.2)
510(k) K252440
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK252440 | Date2 Oct 2025 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
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, 18 Sep 2026
The EasyTeleMed (2.0.2) is a Transmitter and Receiver, Physiological Signal, Radiofrequency, designed for wireless monitoring and transmission of cardiovascular parameters. It facilitates real-time data acquisition and telemetry, enabling remote patient assessment and diagnostic support in clinical settings.
This device is intended for use in healthcare environments, supplied as a reusable system with FDA 510(k) and MDR authorisations. It operates within Class II regulatory classification and is not classified as MRI-safe. The device requires proper calibration, maintenance, and adherence to manufacturer guidelines for optimal performance and safety. No specific sterility or single-use designation is indicated in the provided data.
Other devices from Ingeniars S.R.L.
Questions
AI-generated answers, 18 Sep 2026
What types of cardiovascular parameters can the EasyTeleMed (2.0.2) monitor and transmit in real-time?
The EasyTeleMed (2.0.2) is designed for wireless monitoring and transmission of cardiovascular parameters, enabling real-time data acquisition. While the exact parameters aren’t specified, its classification as a 'Transmitter and Receiver, Physiological Signal, Radiofrequency' suggests it captures metrics like heart rate, blood pressure, or ECG signals for remote patient assessment in clinical settings.
Is the EasyTeleMed (2.0.2) system reusable or single-use, and what does this mean for maintenance?
The device is explicitly described as a reusable system, meaning it is intended for repeated use across multiple patients after proper cleaning, calibration, and maintenance. This requires adherence to manufacturer guidelines to ensure accuracy, safety, and compliance with regulatory standards like FDA 510(k) and MDR authorizations.
How is the EasyTeleMed (2.0.2) regulated, and what does this imply for healthcare providers?
The EasyTeleMed (2.0.2) holds FDA 510(k) clearance and MDR authorization, classifying it as a Class II medical device under regulatory oversight. This means it undergoes rigorous review for safety and performance, and providers must follow manufacturer instructions for calibration, maintenance, and proper use to comply with regulatory requirements.
Does the EasyTeleMed (2.0.2) require any special storage conditions, and is it compatible with MRI environments?
The device is not classified as MRI-safe, so it should not be used or stored near MRI machines. While specific storage conditions aren’t detailed, reusable medical devices like this typically require protection from physical damage, extreme temperatures, and contamination to maintain functionality and sterility (if applicable). Always follow the manufacturer’s storage guidelines.
What should clinicians consider when integrating the EasyTeleMed (2.0.2) into their workflow for remote patient monitoring?
The EasyTeleMed (2.0.2) enables wireless, real-time cardiovascular monitoring, ideal for remote patient assessment in clinical settings. Clinicians should verify compatibility with their existing telemetry systems, ensure proper calibration and maintenance per manufacturer instructions, and confirm network reliability for uninterrupted data transmission. Its reusable design also requires a cleaning protocol to prevent cross-contamination.