# K072294: System-Mini, Models: 390, E30

- Pathway: 510(k) (Special)
- Applicant: Bio-Medical Research, Ltd.
- Decided: Oct 25, 2007 after 70 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.
No later device cites it as a predicate yet.
0 of 5 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.

## Indications for use
System-Mini, Type 390, Model E30 is indicated for the strengthening, toning and firming of the bottom.

Source page: https://510kreport.com/device/K072294
Methodology: https://510kreport.com/methodology