# K252440: EasyTeleMed (2.0.2)

- Pathway: 510(k) (Traditional)
- Applicant: Ingeniars S.R.L.
- Decided: Oct 2, 2025 after 59 days
- Product code: DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 870.2910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K864318 (1987). 102 ancestors in all.
No later device cites it as a predicate yet.
0 of 103 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211822: LifePath Remote Patient Monitoring Platform, Elastic Care Incorporated (2022) Summary page 5.
- K181248: Comarch e-Care Platform, Comarch Healthcare SA (2018) Summary page 5.
- K211365: Alio Medical Remote Monitoring System, Graftworx, Inc. Dba Alio (2022) Summary page 5.
- K152139: Vital Connect Platform, HealthPatch MD, VitalPatch, Vitalconnect, Inc. (2015) Summary page 5.

## Indications for use
EasyTeleMed mobile applications (Home and Professional) connect with compatible physiological measurement devices intended to be used at home or healthcare-related environments to collect physiological parameters measurements and securely transmit them unaltered to the EasyTeleMed EMR Plus. The physiological parameters that can be acquired are: • Blood pressure (systolic/diastolic) • Heart rate (from ECG or auscultation) • Pulse rate (form finger or arm) • Body weight •ECG • Blood glucose • Pulse oximetry • Spirometry • Body temperature • Respiratory rate • Cardiac auscultation • Pulmonary auscultation EasyTeleMed serves as Software as a Medical Device and can be used only with specific FDA cleared or approved third-party measurement devices. EasyTeleMed securely stores the collected information and makes it available for viewing by remotely located clinicians using EasyTeleMed EMR Plus, accessible via a web browser. The clinician can analyze the data, prescribe medications, set up a care plan or contact the patient if needed (via message or video calls). Clinicians can set rules (activities and thresholds) individually for each patient and for any rule breach, notification is sent to the clinician, if desired. EasyTeleMed does not interpret, make diagnoses nor serve as a substitute for medical care. It is not intended to provide real-time data. EasyTeleMed is contraindicated for use in high-acuity environments, such as the ICU or operating rooms, and is not intended to use on acutely or critically ill patients or those requiring time-critical or emergency intervention. EasyTeleMed is not intended for use in settings and on patients where the nature of changes in vital parameters is such that they could create an immediate danger to the patient. EasyTeleMed is intended for patients who are willing and capable of managing its use or can be assisted by a caregiver. Clinical judgement and experience by a clinician are required to check and interpret the information delivered.

Source page: https://510kreport.com/device/K252440
Methodology: https://510kreport.com/methodology