# K010997: PAM-RL

- Pathway: 510(k) (Traditional)
- Applicant: Individual Monitoring Systems, Inc.
- Decided: Oct 15, 2001 after 195 days
- Product code: GWQ (Full-Montage Standard Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K854030 (1986). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992410: Actitrac, Individual Monitoring Systems, Inc. (1999) Summary page 2.

## Indications for use
The PAM-RL is a small, limb-worn activity monitor, typically placed on the leg or wrist, designed for documenting physical movements associated with applications in physiological monitoring. The device is intended to monitor 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/K010997
Methodology: https://510kreport.com/methodology