# K253636: Zionic Pro Max (EMS)

- Pathway: 510(k) (Traditional)
- Applicant: Termosalud S.L.
- Decided: Mar 12, 2026 after 113 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: 8 generations back to K881114 (1988). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201653: Compex Sport Elite 3.0, Djo, LLC (2020) Summary page 5.

## Indications for use
The Zionic Pro Max EMS function of the device is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The work imposed on the muscles by the Zionic Pro Max programs is not suitable for rehabilitation or physiotherapy.

Source page: https://510kreport.com/device/K253636
Methodology: https://510kreport.com/methodology