# K122333: Mobilecare Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Aframe Digital, Inc.
- Decided: Nov 19, 2012 after 109 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). 63 ancestors in all.
No later device cites it as a predicate yet.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103796: Telemedcare Health Monitor, Telemedcare Pty, Ltd. (2011) Summary page 1.

## Indications for use
The MobileCare MonitorM remote monitoring system is intended as a support in the care of patients and the elderly in institutional, home, and community care settings. Intended users include the monitored individuals and their caregivers. MobileCare Monitor includes a MyPHD T personal help device that is intended to monitor patients and the elderly as they go about their daily activities. MyPHO can be affixed to the wrist, clipped to the waist or used in a bandage for attachment at other locations on the monitored individual, as determined by the patient or caregiver. MobileCare monitor provides the MyPHO location information, battery life and indication that it is being worn. MyPHO also includes a help button and a tn-axial accelerometer used to convey the degree of motion created by a wearer's movements to support an assessment of impacts. MobileCare Monitor may also relay physiological data from legally marketed Class I and Class II wireless medical devices (e.g. blood pressure cuff, weight scale, blood glucometer, pulse-oximeter, etc.) to AlFrame Digital secure remote servers by means of industry standard networks and public carriers. Physiological data transmitted from these devices are stored and may be retrieved with a secure web browser after the user presents satisfactory security credentials. Users may also request the data to be presented in graphical format. Alerts can be sent when a patient presses a help button on the myPHD or when any data value from MyPHD or relayed device exceeds an upper or lower limit threshold established by a user. These data include impact sensitivity settings and/or physiological measurements from relayed Class I and Class 11 devices. Rules may be created for reminders to be scheduled for periodic physiological measurements. Alerts are sent to the browser or to a computer or mobile device address that the user designates. MobileCare Monitor is not interpretive or predictive, nor is it intended to provide an automated treatment decision or act as a substitute for professional healthcare judgment. All patient medical diagnosis and treatment are to be performed under the direct supervision and oversight of an appropriate healthcare professional.

Source page: https://510kreport.com/device/K122333
Methodology: https://510kreport.com/methodology