# K022719: Physical Monitoring Registration Unit

- Pathway: 510(k) (Traditional)
- Applicant: Maryrose Cusimano, Ph.D./Phil Reaston
- Decided: Nov 13, 2002 after 90 days
- Product code: IKN (Electromyograph, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 890.1375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K890495 (1989). 5 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002104: Combined Physiological Monitoring System, Maryrose Cusimano, Ph.D. & Scott Zeff (2000)
- K944787: Integrated Movement Analyzer, Maryrose (1995) Summary page 1.
- K914920: Biofeedback System/3, Davicon, Inc. (1992) Summary page 1.
- K901732: Emg Accessory for Posturography, Neurocom International, Inc. (1991) Summary page 1.
- K890495: Nicolet Viking II System, Nicolet Instrument Corp. (1989) Summary page 1.

## Most influential descendants
- K031995: Comprehensive Neuromuscular Profiler (2004), 2 descendants of its own
- K113074: Cmap Pro (2012), 1 descendant of its own
- K173510: BioStamp nPoint (2018), 0 descendants of its own
- K123902: Physical Monitoring Registration Unit-S (Pmru-S) (2013), 0 descendants of its own

## Indications for use
Surface electromyography with range of motion, functional capacity assessment grip and pinch strength.

Source page: https://510kreport.com/device/K022719
Methodology: https://510kreport.com/methodology