# K252154: Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Longest Medical Technology Co., Ltd.
- Decided: Dec 9, 2025 after 153 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 K881114 (1988). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201653: Compex Sport Elite 3.0, Djo, LLC (2020) Summary page 5.

## Indications for use
The NMES is used for: The device is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The work imposed on the muscles by the NMES programs is not suitable for rehabilitation and physiotherapy. The TENS is intended for: a) Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities; b) The symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

Source page: https://510kreport.com/device/K252154
Methodology: https://510kreport.com/methodology