# K132179: Arasys

- Pathway: 510(k) (Traditional)
- Applicant: Ion Genius, Inc.
- Decided: Apr 28, 2014 after 287 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: 3 generations back to K940301 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123158: Ion Magnum Genius, Ion Genius, Inc. (2013) Summary page 3.

## Indications for use
Arasys Genius is intended for muscle conditioning to stimulate healthy muscles. The Arasys 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 Arasys Genius programs is designed for injured or ailing muscles and its use on such muscles is contraindicated. The Amasys Genius is only offered under prescription given by a physician licensed in the state in which he or she practices. The Arasys Genius is intended to be operated by a trained professional who is always present to monitor treatment.

Source page: https://510kreport.com/device/K132179
Methodology: https://510kreport.com/methodology