# K253790: High Intensity Focused Electromagnetic Stimulation Device (FE60)

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Winkonlaser Technology Limited
- Decided: Aug 13, 2026 after 258 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: 9 generations back to K010335 (2001). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250038: Muscle Stimulator Device (PZ-100), Zhengzhou PZ Laser Slim Technology Co., Ltd. (2025) Summary page 6.

## Indications for use
The FE60 is indicated to be used for: • Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen. • Strengthening, Toning and Firming of buttocks, thighs and calves. • Improvement of muscle tone and firmness, for strengthening muscles in arms.

Source page: https://510kreport.com/device/K253790
Methodology: https://510kreport.com/methodology