# K142055: Gymform Abs & Core

- Pathway: 510(k) (Traditional)
- Applicant: Well Brain International, Ltd.
- Decided: May 11, 2015 after 286 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: 7 generations back to K010335 (2001). 24 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130074: Gymform Abs-a-Round, Well Brain International, Ltd. (2013) Summary page 5.
- K111476: Contour Technology Muscle Stimulator, Contour Technology (2012) Summary page 5.

## Most influential descendants
- K181728: Muscle Trainer (2018), 0 descendants of its own

## Indications for use
GYMFORM®ABS& CORE is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The ABS& CORE may be considered a technique or method for muscle training. 2-area belt is intended for use on the muscles in abdomen or lower back separately. Mini belt is intended for use on the muscles in arms, legs, thighs or buttocks areas separately.

Source page: https://510kreport.com/device/K142055
Methodology: https://510kreport.com/methodology