# K070109: Neurometrix Advance

- Pathway: 510(k) (Traditional)
- Applicant: Neurometrix, Inc.
- Decided: Apr 25, 2008 after 470 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: 5 generations back to K802637 (1980). 9 ancestors in all.
15 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944547: Dantec Keypoint, Mckenna & Cuneo (1995) Summary page 1.
- K060584: NC-Stat, Neurometrix, Inc. (2006) Summary page 1.
- K041320: Modification to NC-Stat, Neurometrix, Inc. (2004) Summary page 1.
- K013459: Modification of NC-Stat, Neurometrix, Inc. (2002) Summary page 1.

## Most influential descendants
- 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
- K243495: Natus Ultrapro S100 (982A0594) (2024), 1 descendant of its own

## Indications for use
NeuroMetrix ADVANCE is intended to perform nerve conduction studies and needle electromyography procedures. As such, NeuroMetrix ADVANCE is intended to measure neuromuscular signals that are useful as an aid in diagnosing and evaluating patients suspected of having focal or systemic neuropathies. If the elective needle EMG module is used, then the device is also intended to measure signals that are useful as an aid in evaluating disorders of muscles. This device must be used in the context of other patient information. Its output must be reviewed and interpreted by a physician who will exercise professional judgment when using this information.

Source page: https://510kreport.com/device/K070109
Methodology: https://510kreport.com/methodology