# K052969: Slendertone Gymbody, Model 512-01

- Pathway: 510(k) (Special)
- Applicant: Bio-Medical Research, Ltd.
- Decided: Nov 16, 2005 after 26 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.
No later device cites it as a predicate yet.
0 of 2 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.

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

Source page: https://510kreport.com/device/K052969
Methodology: https://510kreport.com/methodology