# K100320: Slendertone System Ultra Model E70/X70

- Pathway: 510(k) (Special)
- Applicant: Bio-Medical Research, Ltd.
- Decided: May 5, 2010 after 90 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: 3 generations back to K010335 (2001). 4 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070142: Slendertone System Abs, Models 390, E10, X10; Slendertone System Shorts, Models 390, E20, Bio-Medical Research Corp. (2007) Summary page 1.

## Most influential descendants
- K180688: SLENDERTONE CoreFit Abs 8, Type 734 (2018), 1 descendant of its own
- K151903: Slendertone connect Abs (2015), 1 descendant of its own
- K203513: SLENDERTONE Evolve Abs, Type 735 (2021), 0 descendants of its own
- K161974: SLENDERTONE® Connect Abs, Type 570 (2016), 0 descendants of its own

## Indications for use
The Slendertone System Ultra is indicated for the improvement of abdominal muscle tone, for the strengthening of the abdominal muscles and for the development of a firmer abdomen.

Source page: https://510kreport.com/device/K100320
Methodology: https://510kreport.com/methodology