# K102295: X2ABS Dual Channel Fitness Belt

- Pathway: 510(k) (Traditional)
- Applicant: Leto Enterprises Incorporation
- Decided: Feb 18, 2011 after 189 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: 4 generations back to K010335 (2001). 4 ancestors in all.
7 later devices descend from it; 4 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)
- K081026: Body Control System Family, Body Control Duo and CT5, Sport-Elec S.A. (2008) Summary page 2.

## Most influential descendants
- K130074: Gymform Abs-a-Round (2013), 3 descendants of its own
- K142055: Gymform Abs & Core (2015), 1 descendant of its own
- K202653: Gymform Total ABS (2021), 0 descendants of its own
- K181728: Muscle Trainer (2018), 0 descendants of its own
- K152128: 2-in-1 Abdominal Muscle Training & Back Pain Relief System (2015), 0 descendants of its own

## Indications for use
The X2ABS Dual Channel Fitness Belt is indicated for the improvement of muscle tone, for strengthening of muscles and for the development of firmer muscles. It is indicated for use on the abdominal muscles. Contraindicated use on injured or otherwise impaired muscles. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.

Source page: https://510kreport.com/device/K102295
Methodology: https://510kreport.com/methodology