# K090138: Mobilecare Monitor, Model 2100

- Pathway: 510(k) (Traditional)
- Applicant: Aframe Digital, Inc.
- Decided: Apr 24, 2009 after 93 days
- Product code: KMI (Monitor, Bed Patient)
- Device class: 1
- Regulation: 21 CFR 880.2400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K925529 (1993). 1 ancestor in all.
14 later devices descend from it; 4 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925529: Wander Care, Care Electronics, Inc. (1993) Summary page 3.
- (no number) Stanley Security Solutions, Inc., Senior Technologies Div. TABS Elite and Wireless TABs Bed and Chair Exit Monitor System: named in the summary without a submission number

## Most influential descendants
- K101109: Vivatrak (2010), 12 descendants of its own
- K130752: Dynasense System (2013), 6 descendants of its own
- K141877: Leaf Patient Monitoring System (2014), 5 descendants of its own
- K191882: Masimo Centroid System (2020), 3 descendants of its own
- K103536: Ibed Wireless with Ibed Awareness (2010), 3 descendants of its own

## Indications for use
The MobileCareTM Monitor 2100 system includes a MyPHD TM personal help device that is intended to monitor residents in home and long-term care facilities including independent living, assisted living and rehabilitation settings. The monitor can be placed on the wrist using the Velcro strap and used like a watch by the resident. The other form of MyPHD offered has no wrist straps so it can be clipped to the waist or used in a bandage for attachment at other locations on the person as may be appropriate or preferred by the user or healthcare provider. The system provides an alert to designated caregivers or professional staff automatically at pre-set thresholds to indicate an impact has occurred. The system also includes an emergency (panic) button that can be pressed by the monitored individual to alert caregivers as needed. The users of the system include staff and residents. The product is intended to be used on a 24-hour basis. The system is not intended to provide automated treatment decisions, nor is it to be used as a substitute for professional healthcare judgment. All patient medical diagnosis and treatment are to be performed under direct supervision and oversight of an appropriate healthcare professional.

Source page: https://510kreport.com/device/K090138
Methodology: https://510kreport.com/methodology