# K201845: Portable Electro-Stimulation Therapy Device, Model: LGT-232(US)

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Longest Science & Technology Co., Ltd.
- Decided: Oct 8, 2020 after 94 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). 35 ancestors in all.
No later device cites it as a predicate yet.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170903: Compex Wireless USA, Djo, LLC (2017) Summary page 5.
- K200727: TENS and Muscle Stimulator, Shenzhen Astec Technology Co., Ltd. (2020) Summary page 5.

## Indications for use
The Portable Electro-Stimulation Therapy Device, model LGT-232(US) is used to: Stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only. Portable Electro-Stimulation Therapy Device, model LGT-232(US) in TENS mode is used for: 1. Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities; 2. The symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

Source page: https://510kreport.com/device/K201845
Methodology: https://510kreport.com/methodology