# K233987: Veraband™

- Pathway: 510(k) (Traditional)
- Applicant: Arbor Medical Innovations, LLC
- Decided: Jun 17, 2024 after 182 days
- Product code: LEL (Device, Sleep Assessment)
- Device class: 2
- Regulation: 21 CFR 882.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K854030 (1986). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132764: Motion Watch and Pro-Diary, Camntech, Ltd. (2014) Summary page 5.
- K080545: Actitrainer, Actigraph, LLC (2008) Summary page 5.

## Indications for use
The VERABAND™ is a compact, lightweight, body-worn activity monitoring device designed to document physical movement associated with applications in physiological monitoring. The device is intended to monitor limb or body movements during daily living and sleep for a limited time interval (up to 30- days). The VERABAND™ can be used to assess activity in any instance where quantifiable analysis of physical motion is desired. VERABAND™ is not intended for diagnostic purposes.

Source page: https://510kreport.com/device/K233987
Methodology: https://510kreport.com/methodology