# K250038: Muscle Stimulator Device (PZ-100)

- Pathway: 510(k) (Traditional)
- Applicant: Zhengzhou PZ Laser Slim Technology Co., Ltd.
- Decided: May 19, 2025 after 131 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: 8 generations back to K010335 (2001). 19 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190456: BTL 799-2L, BTL Industries, Inc. (2019) Summary page 6.

## Most influential descendants
- K253790: High Intensity Focused Electromagnetic Stimulation Device (FE60) (2026), 0 descendants of its own

## Indications for use
The Muscle Stimulator Device 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/K250038
Methodology: https://510kreport.com/methodology