# K182440: Body System

- Pathway: 510(k) (Traditional)
- Applicant: A-1 Engineering
- Decided: Feb 26, 2019 after 172 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: 5 generations back to K940301 (1994). 6 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 12 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 5.
- K143551: Compex Wireless USA, Djo, LLC (2015) Summary page 6.

## Most influential descendants
- 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
- K233470: Deka Lily (2023), 0 descendants of its own

## Indications for use
The Body System is intended for muscle conditioning to stimulate healthy muscles. The Body System is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. The Body System is intended to be operated by a trained professional who is present to monitor treatment.

Source page: https://510kreport.com/device/K182440
Methodology: https://510kreport.com/methodology