# K083862: Medapps 2.0 Remote Patient Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Medapps, Inc.
- Decided: Jun 5, 2009 after 158 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: 12 generations back to K864318 (1987). 60 ancestors in all.
12 later devices descend from it; 7 cite it directly.
0 of 73 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.

## Most influential descendants
- K124000: Medapps 2.0 - Remote Patient Monitoring System (2013), 4 descendants of its own
- K112559: Medapps 2.0 Remote Patient Monitoring System (2011), 4 descendants of its own
- 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

## Indications for use
The MedApps 2.0 - Remote Patient Monitoring System consists of a patient device, MedApps HealthPAL, which is a mobile Over-The-Counter wireless communication hub that connects to commercially available wireless and tethered Glucose Meters, Scales, Blood Pressure Monitors and Pulse Oximeters. The HealthPAL stores and displays the information on the OLED screen, and transmits the information to the MedApps secure host server called "HealthCOM" using off the shelf FCC approved wireless / cellular connectivity (including, but not limited to 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 MedApps 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/K083862
Methodology: https://510kreport.com/methodology