# K112559: Medapps 2.0 Remote Patient Monitoring System

- Pathway: 510(k) (Special)
- Applicant: Medapps, Inc.
- Decided: Dec 2, 2011 after 91 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: 13 generations back to K864318 (1987). 61 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080798: Intel Health Guide, Model: PHS6000, Intel Corp. (2008) Summary page 1.
- K072698: Confidant 2.5, Confidant, Inc. (2007) Summary page 1.
- K062377: Medapps Remote Patient Monitoring, Model MA 100, Medapps, Inc. (2007) Summary page 1.
- K083862: Medapps 2.0 Remote Patient Monitoring System, Medapps, Inc. (2009) Summary page 1.

## Most influential descendants
- K133252: Healthinterlink Beacon (2014), 3 descendants of its own
- K181248: Comarch e-Care Platform (2018), 2 descendants of its own
- K211822: LifePath Remote Patient Monitoring Platform (2022), 1 descendant of its own
- K252440: EasyTeleMed (2.0.2) (2025), 0 descendants of its own

## Indications for use
The MedApps 2.0 - Remote Patient Monitoring System consists of a patient device, MedApps HealthPAL, a mobile over-the-counter wireless communication hub, or MedApps HealthAIR, a portable over-the-counter wireless communication hub, which connects to commercially available glucose meters, scales, blood pressure monitors and pulse oximeters and HealthCOM, MedlApps' secure host server system. MedApps Remote Patient Monitoring devices receive and store measurements collected from the described monitors, either wirelessly (HealthPAL) or tethered (HealthPAL or HealthAIR). MedApps devices do not alter the indicated use of the peripheral monitors that they integrate with. MedApps devices indicate successful or failed reception and transmission of data with visual and audio cues (HealthPAL via OLED display screen, verbal message and audio tones; HealthAIR via LED lights and audio tones). MedApps devices store collected data and transmit to HealthCOM using commercially available, FCC compliant, wireless telecommunication protocols (including but not limited to cellular GSM, CDMA and WiMax). Healthcare professionals can review the transmitted information within the MedApps HealthCOM system, set thresholds to flag readings based on specific thresholds being exceeded. In addition, the MedApps Interactive Voice Response (IVR) has the ability to contact the patient remotely and use pre-approved ("canned") educational or reminder messages. ("Your nurse would like to talk to you, can I connect you now", "We haven't received a reading from you today, please send us your readings"). The MedlApps 2.0 - Remote Patient Monitoring System is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. The data is made available to the patients when time-critical care is not required. The device is contraindicated for patients requiring direct medical supervision or emergency intervention.

Source page: https://510kreport.com/device/K112559
Methodology: https://510kreport.com/methodology