# K971143: Neuro Pulse II,Iii

- Pathway: 510(k) (Traditional)
- Applicant: Aaron Medical Industries
- Decided: Jun 6, 1997 after 70 days
- Product code: ETN (Stimulator, Nerve)
- Device class: 2
- Regulation: 21 CFR 874.1820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The subject device of this premarket notification submission (K-971143) is indicated for use as a nerve stimulator to assist in the location of individual motor nerves during hand and facial reconstructive surgery.

Source page: https://510kreport.com/device/K971143
Methodology: https://510kreport.com/methodology