# K010335: Slendertone Flex, Model, 512

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Medical Research, Ltd.
- Decided: Sep 27, 2001 after 237 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
No predicates in its family tree.
73 later devices descend from it; 9 cite it directly.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K030708: Slendertone Flex Abdominal Training System, Type 515 (2003), 64 descendants of its own
- K022855: Slendertone Flex Bottom & Thigh Toning System, Type 511 (2003), 53 descendants of its own
- K070142: Slendertone System Abs, Models 390, E10, X10; Slendertone System Shorts, Models 390, E20 (2007), 52 descendants of its own
- K061914: Sport-Elec, Models Duo CT5 Slimness and CT5 Slimness (2007), 32 descendants of its own
- K081026: Body Control System Family, Body Control Duo and CT5 (2008), 31 descendants of its own

Source page: https://510kreport.com/device/K010335
Methodology: https://510kreport.com/methodology