# K110334: Waldo Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Waldo Health
- Decided: Apr 12, 2011 after 67 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.
1 later device descends from it; 1 cites it directly.
0 of 63 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.
- K083862: Medapps 2.0 Remote Patient Monitoring System, Medapps, Inc. (2009) Summary page 1.

## Most influential descendants
- K111922: Vocare Myhealth Tablet (2011), 0 descendants of its own

## Indications for use
The Waldo Patient Monitor is a remote patient monitor device available by prescription. The Waldo Patient Monitor is designed to be used in the home of a patient undergoing remote monitoring for maintenance of chronic disease. The Waldo Patient Monitor provides guidance in operating medical sensor devices, reminders for medication compliance and connectivity to healthcare professionals through text messaging and rear-time video conferencing technology. The Waldo Patient Monitor connects to commercially available wireless and tethered glucose meters, weight scales, blood pressure monitors and pulse oximeters. The Waldo Patient Monitor stores and displays the information on the LCD screen and transmits the information to the Waldo Health secure host server using connectivity including, but not limited to, FCC approved Wi-Fi, Cellular Wireless Internet or Ethernet. Healthcare professionals can review the transmitted information utilizing the Waldo Health Clinician Access System and set thresholds to trigger alerts based on specific thresholds being exceeded. The Waldo Health 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. The system is intended for patients who are willing and capable of managing its use. Judgment and experience by a caregiver or by a family member are required to check and interpret the information delivered. A list of devices that are compatible with the Waldo Patient Monitor will be available in the user's manual and the Waldo Health website.

Source page: https://510kreport.com/device/K110334
Methodology: https://510kreport.com/methodology