# K091833: Gem-Stone Abdominal Training System; Model Gem-Tone 310PE/320PE/330PE/340PE/350PE.

- Pathway: 510(k) (Traditional)
- Applicant: Gemore Technology Co, Ltd.
- Decided: Oct 16, 2009 after 116 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: 1 generation back to K010335 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010335: Slendertone Flex, Model, 512, Bio-Medical Research, Ltd. (2001) Summary page 1.

## Most influential descendants
- K102926: Gemore Muscle Conditioner; (2011), 0 descendants of its own

## Indications for use
The GEMORE GEM-TONE Abdominal Training System/model GEM-TONE 31OPE/320PE/330PE/340PE/350PE are the electrical muscle stimulator intended for the following indication for use: Strengthening, toning and firming of the abdomen region. The GEMORE GEM-TONE Abdominal Training System and its stimulation programs are not designed for injured or ailing muscles, and use on such muscles is contraindication.

Source page: https://510kreport.com/device/K091833
Methodology: https://510kreport.com/methodology