# K082614: Evox Electro Diagnostic Device

- Pathway: 510(k) (Traditional)
- Applicant: Laborie Medical Technologies, Inc.
- Decided: Mar 6, 2009 after 178 days
- Product code: GWF (Stimulator, Electrical, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K924723 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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.
- K962455: Four-Channel Preamplifier, Cadwell Laboratories, Inc. (1997) Summary page 1.

## Indications for use
The EVOX Electro Diagnostic Device is intended for the testing of sacral reflexes, pudendal nerve terminal motor latency (PNTML) studies, electromyography (EMG), and cerebral pudendal somatosensory evoked potential (SEP).

Source page: https://510kreport.com/device/K082614
Methodology: https://510kreport.com/methodology