# K181419: Flix-Ems

- Pathway: 510(k) (Traditional)
- Applicant: Casgarum Investment, S.L.
- Decided: May 14, 2019 after 348 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: 7 generations back to K881114 (1988). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133225: E-Fit EF-1280 Ems Machine, Fit-Pro Kft, Ltd. (2014) Summary page 4.
- K170903: Compex Wireless USA, Djo, LLC (2017) Summary page 4.

## Indications for use
FLIX-EMS device is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only. FLIX-EMS is not intended for adjunctive therapy in the treatment of medical diseases and conditions of any kind. None of the FLIX-EMS stimulation programs are designed for injured or disease afflicted muscles. Its use on such muscles is contraindicated. The work imposed on the muscles by the FLIX-EMS programs is definitely not suitable for rehabilitation and physiotherapy. FLIX-EMS electrical impulses allow the triggering of action potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones 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

Source page: https://510kreport.com/device/K181419
Methodology: https://510kreport.com/methodology