# K232409: Electromagnetic Stimulation Systems

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Apolo Medical Technology Co., Ltd.
- Decided: Apr 10, 2024 after 244 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)
- K200382: BTL-703-2, Btl (2021) Summary page 5.

## Indications for use
The Electromagnetic Stimulation System 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/K232409
Methodology: https://510kreport.com/methodology