# K181728: Muscle Trainer

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Kentro Medical Electronics Co., Ltd.
- Decided: Oct 17, 2018 after 110 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). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142055: Gymform Abs & Core, Well Brain International, Ltd. (2015) Summary page 4.
- K171803: HIVOX OTC Electrical Stimulator, Hivox Biotek, Inc. (2017) Summary page 4.

## Indications for use
To be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Source page: https://510kreport.com/device/K181728
Methodology: https://510kreport.com/methodology