# K182020: Portable Electro-Stimulation Therapy Device

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Longest Science & Technology Co., Ltd.
- Decided: Sep 17, 2020 after 783 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: 7 generations back to K881114 (1988). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170918: Compex Sport Elite, Djo, LLC (2017) Summary page 5.

## Indications for use
Portable Electro-Stimulation Therapy Device, model LGT-231 is to be used by adults only and has two modes NMES, TENS. NMES is used to: stimulate healthy muscles in order to improve or facilitate muscle performance. TENS is used to: 1. Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities. 2. Symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

Source page: https://510kreport.com/device/K182020
Methodology: https://510kreport.com/methodology