# K151784: ActTrust

- Pathway: 510(k) (Traditional)
- Applicant: Condor Instruments Ltda. - Epp
- Decided: May 25, 2016 after 329 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)
- K983533: Actiwatch, Mini-Mitter Co., Inc. (1999) Summary page 4.
- K132764: Motion Watch and Pro-Diary, Camntech, Ltd. (2014) Summary page 4.
- K111514: SBV2, Multicharger Model MC10V2, Sleep Performance D.B.A. Fatigue Science (2011) Summary page 4.

## Indications for use
The ActTrust is an ultra-compact, lightweight, wrist-worn activity, temperature and ambient light monitor that can be used to analyze circadian rhythms, automatically collect and store data for sleep parameters, and assess activity in any instance where quantifiable analysis of physical motion is desirable. The device is intended to monitor limb or body movements during daily living and sleep. ActTrust is indicated for adults of 22 years of age and over.

Source page: https://510kreport.com/device/K151784
Methodology: https://510kreport.com/methodology