# K122458: Verizon Wireless Remote Health Management System

- Pathway: 510(k) (Traditional)
- Applicant: Cello Partnership D/B/A Verizon Wireless
- Decided: Jul 30, 2013 after 351 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). 26 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092635: Alcatel-Lucent Teleheath Manager, Alcatel-Lucent Canada, Inc. (2009) Summary page 1.
- K113446: Vignet Telehealth Manager, Vignet, Inc. (2012) Summary page 1.

## Most influential descendants
- K132930: Myhealthpoint Telehealth Manager (2014), 0 descendants of its own
- K134004: Verizon Wireless Converged Health Management Device (2014), 0 descendants of its own

## Indications for use
The OHM Device is a remote monitoring software solution intended to collect and store biometric data from physiological measurement devices intended for use in the home. The CHM Device also allows for the automated transmission of the biometric data to a remote secure server via existing mobile telecommunications and/or Internet infrastructure. The stored biometric data is accessible by clinicians for analysis and intervention. Patients can also review the stored biometric data and receive educational and motivational content from clinicians. The OHM Device can be used as a standalone device or in conjunction with supported patient monitoring devices, such as a glucometer, weight scale, pulse oximeter, and blood pressure monitor. The OHM Device is not intended for use in surgical rooms, intensive care units, intermediate or step-down units or emergency vehicles. It is not interpretive, nor is it intended for diagnosis or as a replacement for the oversight of healthcare professionals. It does not provide real-time or emergency monitoring.

Source page: https://510kreport.com/device/K122458
Methodology: https://510kreport.com/methodology