# K232982: EMS Sculpt Machine

- Pathway: 510(k) (Traditional)
- Applicant: Shandong Huamei Technology Co., Ltd.
- Decided: Nov 25, 2024 after 430 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: 3 generations back to K062439 (2007). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163165: AM-100, BTL Industries, Inc. (2017) Summary page 5.

## Indications for use
The EMS Sculpt Machine 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 and thighs.

Source page: https://510kreport.com/device/K232982
Methodology: https://510kreport.com/methodology