# K202653: Gymform Total ABS

- Pathway: 510(k) (Traditional)
- Applicant: Well Brain International, Ltd.
- Decided: Jan 15, 2021 after 123 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.
No later device cites it as a predicate yet.
0 of 25 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.

## Indications for use
The Gymform® TOTAL ABS (Model: WB-245) is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The large belt is intended for use on the muscles in abdomen. The small belt for working the leg and arm muscles, intended for use on the muscles in arms, legs (lower extremities) and thighs areas separately.

Source page: https://510kreport.com/device/K202653
Methodology: https://510kreport.com/methodology