# K123158: Ion Magnum Genius

- Pathway: 510(k) (Traditional)
- Applicant: Ion Genius, Inc.
- Decided: Jun 21, 2013 after 255 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: 2 generations back to K940301 (1994). 2 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011880: Compex Sport, Compex S.A. (2002) Summary page 2.

## Most influential descendants
- K182440: Body System (2019), 5 descendants of its own
- K213308: Venus BlissMAX (2022), 2 descendants of its own
- K220592: Venus BlissMAX (2022), 1 descendant of its own
- K200545: Legend Pro DMA (2021), 1 descendant of its own
- K252845: Venus Nova (FP-2001) (2025), 0 descendants of its own

## Indications for use
Ion Magnum Genius is intended for muscle conditioning to stimulate healthy muscles. The Ion Magnum Genius is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the Ion Magnum Genius programs is designed for injured or ailing muscles and its use on such muscles is contraindicated. The Ion Magnum Genius is only offered under prescription given by a physician licensed in the state in which he or she practices.

Source page: https://510kreport.com/device/K123158
Methodology: https://510kreport.com/methodology