# K203513: SLENDERTONE Evolve Abs, Type 735

- Pathway: 510(k) (Special)
- Applicant: Bio-Medical Research, Ltd.
- Decided: Feb 10, 2021 after 72 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: 5 generations back to K010335 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180688: SLENDERTONE CoreFit Abs 8, Type 734, Bio-Medical Research, Ltd. (2018) Summary page 4.

## Indications for use
The SLENDERTONE® Evolve Abs, Type 735 is indicated for the improvement of abdominal muscle tone, for strengthening of abdominal muscles, and for the development of a firmer abdomen.

Source page: https://510kreport.com/device/K203513
Methodology: https://510kreport.com/methodology