# K101109: Vivatrak

- Pathway: 510(k) (Traditional)
- Applicant: Wireless Medcare, LLC
- Decided: Jul 15, 2010 after 86 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: 2 generations back to K925529 (1993). 2 ancestors in all.
12 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090138: Mobilecare Monitor, Model 2100, Aframe Digital, Inc. (2009) Summary page 1.
- (no number) TABS Elite: named in the summary without a submission number
- (no number) Roll-Check: named in the summary without a submission number
- (no number) WellAWARE Systems: named in the summary without a submission number
- (no number) SafeBed: named in the summary without a submission number

## Most influential descendants
- 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
- K223498: Radius VSM and Accessories (2023), 1 descendant of its own

## Indications for use
The VivaTRAK™ System monitors in-bed activity and care delivery for patients susceptible to pressure ulcers and falls as well as those that require 24 hour monitoring of their general activity levels in medical, nursing and long-term care facilities including independent living, assisted living and rehabilitation facilities. The system provides care providers information related to patient status and care delivered. The VivaTRAK™ System is not intended to provide automated treatment decisions or be used as a substitute for professional healthcare judgment. The VivaTRAK™ System is not a replacement or substitute for vital signs monitoring or alert equipment. All patient medical diagnosis and treatment are to be performed under direct supervision and oversight of an appropriate health care professional.

Source page: https://510kreport.com/device/K101109
Methodology: https://510kreport.com/methodology