# K181199: Katalyst Mark 1 Muscle Stimulation System Model 2

- Pathway: 510(k) (Traditional)
- Applicant: Katalyst, Inc.
- Decided: Sep 20, 2018 after 136 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). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083140: Compex Sport Plus, Chattanooga Group (2009) Summary page 4.
- K133225: E-Fit EF-1280 Ems Machine, Fit-Pro Kft, Ltd. (2014) Summary page 4.

## Most influential descendants
- K192161: FastFit EMS System (2020), 0 descendants of its own

## Indications for use
The Katalyst Mark 1 is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the training programs or operational parameters are designed to target injured or ailing muscles and its use on such muscles is contraindicated. The Katalyst Mark 1 is Rx only.

Source page: https://510kreport.com/device/K181199
Methodology: https://510kreport.com/methodology