# K132803: Medapps 2.0 Remote Patient Monitoring System, Healthpal, Healthcom, Mobile Link

- Pathway: 510(k) (Special)
- Applicant: Medapps Inc., Dba Alere Connect
- Decided: Dec 12, 2013 after 97 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: 14 generations back to K864318 (1987). 62 ancestors in all.
No later device cites it as a predicate yet.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040966: Modification to Carematix Wellness System, Carematix, Inc. (2004) Summary page 10.
- K083862: Medapps 2.0 Remote Patient Monitoring System, Medapps, Inc. (2009) Summary page 7.
- K124000: Medapps 2.0 - Remote Patient Monitoring System, Medapps Inc., Dba Alere Connect (2013) Summary page 1.

## Indications for use
The MedApps (Alere Connect) 2.0 - Remote Patient Monitoring System consists of 1) a cellular communication hub (MedApps' HealthPAL, Alere MobileLink or Alere HomeLink) an over-the-counter device that resides with the end-user (patient), which connects to commercially available FDA cleared accessory devices, specifically glucose meters, scales, blood pressure monitors, pulse oximeters, and PT/INR monitors (excluding HomeLink) and 2) web-based health data management application (MedApps' HealthCOM), that provides access to collected data stored on a secure host server system. MedApps / Alere Connect Remote Patient Monitoring devices receive and store measurements collected from the described accessory devices, either wirelessly using short-range radio protocols (e.g. Bluetooth, Zigbee, WiFi, Bluetooth Low Energy (BLE), Fitlinxx Radios) or tethered via cable (e.g. USB, serial, etc). Regardless of connectivity mode, the MedApps / Alere Connect monitoring devices do not alter the indications for use of the described peripheral accessory health devices. MedApps / Alere Connect devices indicate successful or failed data reception and transmission with visual and audio feedback using a combination of any of the following: Display, LED Lights, verbal messages, and / or audio tones / chimes. MedApps / Alere Connect devices store collected data and forward / transmit to server for access in HealthCOM via commercially available, FCC compliant, wireless telecommunication protocols (including but not limited to cellular GSM, CDMA and WiMax). Healthcare professionals, clinicians and other authorized personnel can review the transmitted information within the MedApps HealthCOM system, where they can review collected readings, establish parameters to indicate readings exceptions to set thresholds, or trigger Interactive Voice Response (IVR) messages to the patient remotely to issue information such as reminders (e.g. “We haven't received readings from you today, please take and send your readings”) or possibly educational information for conditions such as diabetes, hypertension, CHF, etc. Additionally, HealthCOM can port collected data to the healthcare providers' clinical back-end system(s) of choice. The MedApps /Alere Connect 2.0 Remote Patient Monitoring System is not intended for diagnosis or as a substitute for medical care, nor is it intended to provide real-time / time-critical data. The device is contraindicated for patients requiring direct medical supervision or emergency intervention.

Source page: https://510kreport.com/device/K132803
Methodology: https://510kreport.com/methodology