# K060584: NC-Stat

- Pathway: 510(k) (Traditional)
- Applicant: Neurometrix, Inc.
- Decided: Jul 31, 2006 after 146 days
- Product code: JXE (Device, Nerve Conduction Velocity Measurement)
- Device class: 2
- Regulation: 21 CFR 882.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K802637 (1980). 7 ancestors in all.
18 later devices descend from it; 3 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982359: NC-Stat, Neurometrix, Inc. (1998) Summary page 1.
- K000565: Modification to NC-Stat, Neurometrix, Inc. (2000) Summary page 1.
- K003508: NC-Stat, Neurometrix, Inc. (2001) Summary page 1.
- K013459: Modification of NC-Stat, Neurometrix, Inc. (2002) Summary page 1.
- K041320: Modification to NC-Stat, Neurometrix, Inc. (2004) Summary page 1.
- K802637: Teca Model-10 Electromyograph, Teca, Inc. (1980) Summary page 1.

## Most influential descendants
- K070109: Neurometrix Advance (2008), 15 descendants of its own
- K120979: Carefusion Nicolet Edx (2012), 12 descendants of its own
- K162199: Cascade IOMAX Intraoperative Monitor (2017), 7 descendants of its own
- K212166: ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (2022), 5 descendants of its own
- K130346: Synergy Focus Desktop Version; Synergy Focus Laptop Version (2013), 3 descendants of its own

## Indications for use
The NeuroMetrix NC-stat is intended to stimulate and measure neuromuscular signals that are useful in diagnosing and evaluating systemic and entrapment neuropathies.

Source page: https://510kreport.com/device/K060584
Methodology: https://510kreport.com/methodology