# K091865: Sport-Elec Body Control System

- Pathway: 510(k) (Traditional)
- Applicant: Sport-Elec
- Decided: Nov 13, 2009 after 147 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: 4 generations back to K010335 (2001). 7 ancestors in all.
23 later devices descend from it; 1 cites it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081026: Body Control System Family, Body Control Duo and CT5, Sport-Elec S.A. (2008) Summary page 1.
- K072553: System-Arms, Model 390,E60, Bio-Medical Research, Ltd. (2007) Summary page 1.
- K022855: Slendertone Flex Bottom & Thigh Toning System, Type 511, Bio-Medical Research, Ltd. (2003) Summary page 1.

## Most influential descendants
- K092476: Sport-Elec Body Control System, Model 4M (2010), 22 descendants of its own
- K182106: BTL 799-2T (2018), 12 descendants of its own
- K190456: BTL 799-2L (2019), 11 descendants of its own
- K200382: BTL-703-2 (2021), 4 descendants of its own
- K130074: Gymform Abs-a-Round (2013), 3 descendants of its own

## Indications for use
Body Control System is indicated for the improvement of arms and thighs muscles tone, for strengthening of arms and thighs muscles. Contraindicated use on injured or otherwise impaired muscles Not intended for use in any therapy or for the treatment of any medical conditions or diseases

Source page: https://510kreport.com/device/K091865
Methodology: https://510kreport.com/methodology