# K242186: Neo Sculptor (OF-NEO001)

- Pathway: 510(k) (Traditional)
- Applicant: Ofan Intelligent Technology (Guangzhou) Co., Ltd.
- Decided: Sep 17, 2024 after 54 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The 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 and thighs. •Improvement of muscle tone and firmness, for strengthening muscles in arms.

Source page: https://510kreport.com/device/K242186
Methodology: https://510kreport.com/methodology