# K130074: Gymform Abs-a-Round

- Pathway: 510(k) (Traditional)
- Applicant: Well Brain International, Ltd.
- Decided: Aug 15, 2013 after 213 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: 6 generations back to K010335 (2001). 23 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102295: X2ABS Dual Channel Fitness Belt, Leto Enterprises Incorporation (2011) Summary page 2.
- K111781: Gymform Dual Flex Belt Model WB-162, Well Brain International, Ltd. (2012) Summary page 2.
- K111476: Contour Technology Muscle Stimulator, Contour Technology (2012) Summary page 2.
- K122744: Prospera Otc Tens Electronic Pulse Massager, Prospera Corporation (2013). Cleared while this submission was under review Summary page 2.
- K092476: Sport-Elec Body Control System, Model 4M, Sport-Elec (2010) Summary page 2.

## Most influential descendants
- 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 GYMFORM® ABS-A-ROUND is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The ABS-A-ROUND may be considered a technique or method for muscle training. The 3-area belt is intended for use on the muscles in abdomen, left waist and right waist alternately. The Mini belt accessory is intended for use on the muscles in arms, legs (lower extremities), thighs and buttocks areas separately.

Source page: https://510kreport.com/device/K130074
Methodology: https://510kreport.com/methodology