# K230261: Gnesis EMS Plus

- Pathway: 510(k) (Traditional)
- Applicant: Creative Fitness Developments S.L.
- Decided: Jun 6, 2023 after 126 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: 9 generations back to K881114 (1988). 35 ancestors in all.
No later device cites it as a predicate yet.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181955: WiEMSpro, Medical Cables S.L. (2019) Summary page 5.
- K212413: I-Motion, I-Motion Group Global Iberica S.L. (2022) Summary page 5.

## Indications for use
Gnesis EMS Plus is intended to stimulate healthy muscles in order to improve or facilitate muscle performance, is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of Gnesis EMS Plus training programs is designed for injured or ailing muscles and its use on such cases is contraindicated. Each of Gnesis EMS Plus training programs, depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), is designed for a specific type of exercise. Gnesis EMS Plus is a device for electronic muscle stimulation based on EMS technology. Gnesis EMS Plus is specifically designed as an addition to other sports and for training muscles. It must be used only on healthy muscles, not for rehabilitation purposes.

Source page: https://510kreport.com/device/K230261
Methodology: https://510kreport.com/methodology