# K092476: Sport-Elec Body Control System, Model 4M

- Pathway: 510(k) (Traditional)
- Applicant: Sport-Elec
- Decided: May 7, 2010 after 268 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: 5 generations back to K010335 (2001). 9 ancestors in all.
22 later devices descend from it; 5 cite it directly.
0 of 32 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.
- K091865: Sport-Elec Body Control System, Sport-Elec (2009). Cleared while this submission was under review Summary page 1.
- K092142: Sport-Elec Body Control System BS, Sport-Elec (2010). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- 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
- K240234: BTL-899MS (2024), 2 descendants of its own

## Indications for use
Body Control System 4M is indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs and buttocks areas. 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/K092476
Methodology: https://510kreport.com/methodology