# K111781: Gymform Dual Flex Belt Model WB-162

- Pathway: 510(k) (Traditional)
- Applicant: Well Brain International, Ltd.
- Decided: Jul 11, 2012 after 383 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 K010335 (2001). 2 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030708: Slendertone Flex Abdominal Training System, Type 515, Bio-Medical Research, Ltd. (2003) Summary page 1.

## 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

## Indications for use
The electrical muscle stimulation (EMS) mode of the Gymform Dual Flex Belt is indicated for the improvement of abdominal muscle tone, and for the development of a firmer abdomen. The therapeutic vibrator (Vibration) mode of the Gymnform Dual Flex Belt is indicated for the promotion of muscle relaxation.

Source page: https://510kreport.com/device/K111781
Methodology: https://510kreport.com/methodology