# K191181: NXPRO Neuromuscular Electrical Stimulation Device

- Pathway: 510(k) (Traditional)
- Applicant: Neux Technologies, Inc.
- Decided: Oct 11, 2019 after 162 days
- Product code: NGX (Stimulator, Muscle, Powered, For Muscle Conditioning)
- Device class: 2
- Regulation: 21 CFR 890.5850
- 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 K940301 (1994). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093999: Arp Pov Sport, Arp Manufacturing, Inc. (2010) Summary page 4.

## Indications for use
The NeuX NXPRO Neuromuscular Electrical Stimulation Device is intended for the stimulation of healthy muscles in order to improve or facilitate muscle performance. The NeuX NXPRO is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. The NeuX NXPRO is not designed for use on injured or ailing muscles and its use on such muscles is contraindicated. The NeuX NXPRO’s electrical impulses allow triggering action potential on motor neurons of motor nerves (excitations). These excitations of motor neurons are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, & total session duration), different types of muscle work can be imposed on the stimulated muscles. The various types of muscle work that the NeuX NXPRPO can impose on the stimulated muscles are able to improve or facilitate muscle performance. The NeuX NXPRO is considered a technique of muscle training.

Source page: https://510kreport.com/device/K191181
Methodology: https://510kreport.com/methodology