# K143512: ActiSpec Activity Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Sleep Modus, Inc.
- Decided: Aug 26, 2015 after 258 days
- Product code: ISD (Exerciser, Measuring)
- Device class: 2
- Regulation: 21 CFR 890.5360
- 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). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080545: Actitrainer, Actigraph, LLC (2008) Summary page 4.
- K040554: Actigraph, Model AM7164-2.2 and Actigraph with Extended Memory, Model AM71256, Manufacturing Technology, Inc. (2004) Summary page 4.

## Indications for use
ActiSpec® is a small limb worn activity monitor designed for documenting physical movements associated with applications in physiological monitoring. The device's intended use is to analyze limb activity associated with movement during sleep. The unit can also be used to assess activity in any instance where quantifiable analysis of physical motion is desirable.

Source page: https://510kreport.com/device/K143512
Methodology: https://510kreport.com/methodology