# K223797: Neuro20 Pro System

- Pathway: 510(k) (Traditional)
- Applicant: Neuro20 Technologies
- Decided: Feb 23, 2023 after 66 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: 5 generations back to K940301 (1994). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201975: miha bodytec II, Miha Bodytec GmbH (2021) Summary page 5.
- K090632: Compex Rehab, Chattanooga Group (2009) Summary page 5.

## Indications for use
The Neuro20 PRO System is intended to stimulate muscles in order to improve or facilitate muscle performance. Other indications for use include: • Re-educating muscles • Increasing local blood circulation • Maintaining or increasing range of motion • Relaxation of muscle spasm • Retarding or preventing disuse atrophy

Source page: https://510kreport.com/device/K223797
Methodology: https://510kreport.com/methodology