# K062377: Medapps Remote Patient Monitoring, Model MA 100

- Pathway: 510(k) (Traditional)
- Applicant: Medapps, Inc.
- Decided: Jul 3, 2007 after 322 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K864318 (1987). 22 ancestors in all.
20 later devices descend from it; 5 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061328: Think Positive Diabetes Management System (T+Diabetes System), E-San Limited (2006) Summary page 1.
- K050929: The Hermes System, Palaistra Systems, Inc. (2005) Summary page 1.

## Most influential descendants
- K083862: Medapps 2.0 Remote Patient Monitoring System (2009), 12 descendants of its own
- 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
- K093379: TCX-I-DV Remote Care Management System (2010), 4 descendants of its own
- K133252: Healthinterlink Beacon (2014), 3 descendants of its own

## Indications for use
The MedApps Remote Patient Monitoring System model d-PAL acts as an accessory to FDA cleared devices, which collects and transmits stored patient data via wireless connections from medical devices to a cellular phone (Hub) and forwards to a central server for review of historical data about a patient over time to benefit the Healthcare Practitioner. The following medical devices and measuring systems are fully validated for this intended use at this time: • LifeScan OneTouch ® Ultra® Blood Glucose Monitoring System (k024194/k043197) * Polytel PWR-08-03 Remote Module (k070559) The MedApps Remote Patient Monitoring System is not intended to provide automated treatment decisions or to be used as a substitute for professional healthcare judgment. All patient medical diagnoses and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional. The MedApps Remote Patient Monitoring System is not intended for emergency calls, and may not be used for transmission or indication of any real-time alarms or time-critical data. Clinical judgment and experience are required to check and interpret the measurements collected and transmitted. This device is not for use in systems which substitute for medical care. This device is not intended for patients requiring direct medical supervision or emergency intervention,

Source page: https://510kreport.com/device/K062377
Methodology: https://510kreport.com/methodology