# K232334: Deka Simon

- Pathway: 510(k) (Special)
- Applicant: El.En S.P.A.
- Decided: Sep 1, 2023 after 28 days
- Product code: IPF (Stimulator, Muscle, Powered)
- 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 K945509 (1995). 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)
- K202079: Physiq, El.En Electronic Engineering Spa (2020) Summary page 4.

## Indications for use
The DEKA SIMON device is intended for * Prevention or retardation of disuse atrophy » Maintaining or increasing range of motion * Muscle re-education * Relaxation of muscle spasms * Increasing local blood circulation * Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

Source page: https://510kreport.com/device/K232334
Methodology: https://510kreport.com/methodology