# K192161: FastFit EMS System

- Pathway: 510(k) (Traditional)
- Applicant: Fast Fit, LLC
- Decided: Jan 22, 2020 after 166 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). 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)
- K143551: Compex Wireless USA, Djo, LLC (2015) Summary page 4.
- K181199: Katalyst Mark 1 Muscle Stimulation System Model 2, Katalyst, Inc. (2018) Summary page 4.

## Indications for use
The FastFit EMS System is intended to simulate 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 stimulation programs or operational parameters are designed to target injured or ailing muscles and its use on such muscles is contraindicated. The FastFit EMS System is Rx only.

Source page: https://510kreport.com/device/K192161
Methodology: https://510kreport.com/methodology