# K963208: Nervepace (R) Nerve Conduction Viewscope (200VS)

- Pathway: 510(k) (Traditional)
- Applicant: Neurotron Medical
- Decided: Jul 14, 1997 after 332 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K012069: Modification to:Brevio Nerve Conduction Test Instrument (2001), 1 descendant of its own
- K061828: Lorenz Biotech Aptiva, Version 2.13 (2007), 0 descendants of its own

## Indications for use
The Nervepace® ViewScope 200VS is intended to be used as a waveform display nerve conduction monitor. Currently the digital electroneurometer (K843924A) displays the latency value derived from an action potential. This is accomplished by setting a threshold value into the circuitry and when the onset of the action potential reaches the threshold value it trips the timing circuit and the display shows the latency value in milliseconds from the trigger to the onset. The internal circuitry of the electroneurometer has the complete waveform from which the latency value was derived and this can be delivered to a digital storage oscilloscope for complete waveform display. The latency value is important in the diagnosis of median nerve dysfunction. The physician can use the ViewScope to examine the features of the waveform generated by the stimulus. The physician can determine the action potential latency, amplitude, configuration and duration.

Source page: https://510kreport.com/device/K963208
Methodology: https://510kreport.com/methodology